Clinical Practice Guideline for Multicomponent Behavioral Treatment of Obesity

and Overweight in Children and Adolescents: Current State of the Evidence and

Research Needs

from the Guideline Development Panel (GDP) for Obesity Treatment of the

American Psychological Association (APA)

Adopted as APA policy March 10, 2018

GDP Members:

Maria M. Llabre, Chair

Jamy D. Ard, Vice-Chair

Gary Bennett

Phillip J. Brantley

Barbara Fiese

Jane Gray

Patty Nece

Michele Polfuss

Hollie Raynor

Delia West

Denise Wilfley

APA Guidelines Staff:

Lynn Bufka

Raquel Halfond

Howard Kurtzman

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Abstract

[To be drafted when document is submitted for publication.]

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Table of Contents

Abstract………………………………………………………………………………………………....i

Table of Contents……………………………………………………………………………….…….ii

Disclaimer………………………………………………………………………………..……………..iv

Executive Summary………………………………………………………………………………..…ES-1

Full Guideline…………………………………………………………………………………………..1

Scope of the Guideline

Summary of Recommendations

Introduction to the Topic: Overview of Problem, Healthcare Burden

Current Guidelines for Treatment of Childhood Obesity

Methods and Process …………………………………………………………………………….…13

Vetting and Appointment of Members to the Obesity GDP

Conflicts of Interest

Scoping and Key Questions

Comprehensive Search of the Professional Literature

Development and Use of Evidence Tables

Development and Use of the Grid

Rating of Aggregate/ Global Strength of Evidence (SOE)

Assessing Magnitude of Benefits

Assessing Magnitude of Harms/Burdens

Assessing Patient Values and Preferences

Applicability of Evidence

Decision-Making Regarding Treatment Recommendations

External Review Process

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Recommendations and Statement of Evidence…………………………………………………26

Potential Harms and Burdens of Treatment……………………………………………………..32

Implementation ……………………………………………………………………………………….34

Discussion………………………………………………………………………………………….….37

Applicability of Results and Clinical Significance

Considerations of Patient Values and Preferences

How this Guideline Compares to Other Guidelines for Treatment of Children and

Adolescents with Obesity

Limitations of Existing Treatment Research Literature: Future Research Needs…..…..42

Conflicts of Interest……………………………………………………………………………..….49

Developer…………………………………………………………………………………………….51

Author Disclosures…………………………………………………………………………………51

Funding Source/Sponsor…………………………………………………………………………55

Acknowledgments…………………………………………………………………………………56

References…………………………………………………………………………………………..57

Appendices………………………….………………….………………………………………..…70

A. Definitions of Key Terms……………………………………………………………70

B. APA Declarations/COI Form……………………………………………………….74

C. Voting Procedures Established by Advisory Steering Committee (ASC)……..92

D. Other Organizations’ Clinical Practice Guidelines………………………….……93

E. Systematic Reviews on Medication and Surgery…………………….…………..96

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Disclaimer

This guideline is intended to be aspirational and is not intended to create a requirement

for practice. It is not intended to limit scope of practice in licensing laws for psychologists or for

other independently licensed professionals, nor limit coverage for reimbursement by third party

payers.

The term guidelines refers to statements that suggest or recommend specific

professional behavior, endeavor, or conduct for psychologists. Guidelines differ from standards

in that standards are mandatory and may be accompanied by an enforcement mechanism.

Thus, guidelines are aspirational in intent. They are intended to facilitate the continued

systematic development of the profession and to help assure a high level of professional

practice by psychologists. Guidelines are not intended to be mandatory or exhaustive and may

not be applicable to every professional and clinical situation. They are not definitive, and they

are not intended to take precedence over the judgment of psychologists and other

professionals. Clinical practice guidelines provide research-based recommendations for

treatment of particular conditions (APA, 2015).

In considering the present guideline recommendations, the APA Obesity Guideline

Development Panel (GDP) endorses the following statement from the British National Institute

for Health and Clinical Excellence (NICE), “The recommendations in this guideline represent the

view of NICE [APA], arrived at after careful consideration of the evidence available. When

exercising their judgement, professionals are expected to take this guideline fully into account,

alongside the individual needs, preferences and values of their patients or service users. The

application of the recommendations in this guideline is not mandatory and the guideline does

not override the responsibility of healthcare professionals to make decisions appropriate to the

circumstances of the individual patient, in consultation with the patient and/or their carer or

guardian,” (2009).

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Executive Summary Introduction

Over the past five decades, rates of childhood obesity have increased almost four-fold

(Ogden, Carroll, Kit, & Flegal, 2014). Moreover, there are differences in prevalence rates by

race (American Academy of Family Physicians, 2014; Ogden, Carroll, Fryar & Flegal, 2015) and

socioeconomic status (August et al., 2008; Ogden, Lamb, Carroll & Flegal, 2010), with higher

rates in minority and low socioeconomic status groups. Obesity in children can result in both

immediate and long-term health risks, such as type 2 diabetes, asthma, hypertension,

hyperlipidemia, nonalcoholic fatty liver disease, polycystic ovarian syndrome, obstructive sleep

apnea and musculoskeletal/joint dysfunction (Barlow, 2007; Bass & Eneli, 2015) and is

associated with eating disorders in adulthood (Hilbert et al., 2014). Obesity can also negatively

impact children’s mental health and psychosocial development (Small & Aplasca, 2016).

Children with overweight or obesity may experience weight-based stigmatization. Given the

immediate health and psychosocial consequences, as well as the increased long-term health

risks in adulthood associated with overweight and obesity during childhood, addressing

overweight and obesity during childhood has important positive health implications (Pulgaron,

2013).

Evidence-based clinical practice guidelines are intended to assist the healthcare system

in providing appropriate care, improving quality and consistency of care, and reducing mortality

and morbidity. Guidelines are particularly needed to address care of children and adolescents

with overweight or obesity in order to prevent the onset of more serious health problems.

However, a clinical practice guideline is based on the best available evidence at the time and

should not be construed as a standard of care.

Scope

This guideline is intended to provide treatment recommendations regarding the use of

family-based multicomponent behavioral interventions for overweight (body mass index ≥ 85 %

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percentile for age and gender) and obesity (body mass index ≥ 95 % percentile for age and

gender) in children and adolescents, aged 2-18 years, based on a systematic review of the

evidence. The panel commissioned a systematic review conducted by Kaiser Permanente

Research Affiliates Evidence-based Practice Center (O’Connor, Burda, Eder, Walsh, & Evans,

2016), which served as the evidence base for drafting its recommendations. This guideline

addresses the efficacy of family- based multicomponent behavioral interventions in reducing

and maintaining change in age/sex standardized BMI, particularly a change that is related to

improvements in childhood health. It also reviews how selected intervention characteristics and

strategies, as well as patient1 and family sociodemographic characteristics and patient

adherence, engagement, and retention might impact these interventions and results. This

guideline does not address other treatments for overweight or obesity, screening or assessment

for overweight or obesity and related conditions, treatment follow-up, prevention of overweight

or obesity, costs of treatments, pharmacological or surgical interventions, or availability of care

(see rationale for scope pp. 23).

Key Questions

The panel considered the following five key questions:

1. In children and adolescents with overweight or obesity, do family-based multicomponent

behavioral interventions reduce and maintain change in age/sex- standardized BMI?

2. What is the impact of selected characteristics of family-based multicomponent

behavioral interventions (dosage of contact, setting, interventionist qualifications, mode

of delivery, use of multidisciplinary team, involvement of psychologist, cultural tailoring)

in the management of age/sex-standardized BMI? Specifically:

a. Are these characteristics associated with the efficacy of the interventions

1 To be consistent with other areas of health care, we use the term patient to refer to the child, adolescent, or family receiving care. However, we recognize that in many situations there are important and valid reasons for using such terms as client, consumer or person in place of patient to describe the recipients of services.

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b. What is the comparative effectiveness of these characteristics?

3. How do selected patient and family sociodemographic characteristics (child’s age,

severity of adiposity, parental obesity, race, socioeconomic status) affect family-based

multicomponent behavioral interventions? Specifically, are different strategies used or

needed for families with different sociodemographic characteristics?

4. What is the impact of selected strategies of family-based behavioral interventions (goals

and planning, comparison of outcomes, self-monitoring of behavior, self-monitoring of

outcome, reward and threat, stimulus control, modeling of healthy lifestyle behaviors by

parents, motivational interviewing, general parenting skills [e.g., positive parenting] or

family conflict management) in the management of age/sex standardized BMI?

Specifically:

a. Are these strategies associated with the efficacy of the interventions?

b. What is the comparative effectiveness of these strategies?

5. What is the effect of patient adherence (e.g., percentage of homework completed,

percentage of sessions attended), engagement, and retention on BMI outcomes?

Specifically:

a. What interventions or intervention characteristics and strategies are associated

with these factors?

b. What levels of patient adherence, engagement, and retention are associated with

improved efficacy of the interventions?

This guideline does not address any of the following:

1. Screening for overweight or obesity, treatments other than family-based multicomponent

interventions, assessment of associated conditions, or follow-up after treatment.

2. Prevention of overweight or obesity.

3. Costs of treatments.

4. Availability of care.

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Recommendations

The panel recommends the following:

1. For child and adolescent patients aged 2-18 with overweight or obesity, the panel

strongly recommends the provision of family-based multicomponent behavioral

interventions, with a minimum of 26 contact hours, initiated at the earliest age possible.

There was insufficient evidence to make specific recommendations for subgroups of children or

adolescents based on gender, race/ ethnicity, or socioeconomic status. Studies of children and

adolescents who had eating disorders, were pregnant or post-partum, or had specific medical

conditions (e.g. Prader-Willi syndrome) contributing to their overweight or obesity were not

included in the review and therefore application of the recommendation to individuals from those

groups should be done with particular care, assessing the relationship of these health conditions

to the child or adolescent’s need for this intervention. Furthermore, there was insufficient

evidence to determine whether specific intervention characteristics or strategies were

associated with greater adherence, engagement, or retention. There was also insufficient

evidence to determine whether patient adherence or population characteristics other than child’s

age were associated with efficacy. The evidence supports family-based multicomponent

behavioral interventions that address behavior change, diet and physical activity with sufficient

intensity. Within this framework, providers have flexibility in selecting the specific intervention

program used to accomplish change.

Methods and Process

APA’s Advisory Steering Committee (ASC) issued a call for nominations (including self-

nominations) for individuals to serve as panel members from a variety of backgrounds

(consumer, psychology, psychiatry, general medicine) with content knowledge in the area of

obesity or methodological expertise in systematic reviews or treatment research. Conflicts of

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interest (financial and non-financial) were considered and managed both during panel member

selection and throughout the guideline development process.

After engaging in a discussion of scoping and review of currently existing guidelines, the

panel decided to focus on widely recommended family-based multicomponent behavioral

interventions for children and adolescents. Further, the panel decided to focus on body mass

index (BMI) and standardized BMI (zBMI) and serious adverse events as the critical outcomes.

The panel did not focus on weight loss as some children are continuing to grow and weight loss

may not be necessary to return to a healthy weight range, However, the lack of information on

serious adverse events in the articles resulted in the panel having insufficient empirical data on

this outcome and relying heavily on lower quality evidence (clinician and consumer input) in this

domain. The panel commissioned a systematic review to address questions related to efficacy

of key strategies of multicomponent behavioral interventions for children and adolescents

(O’Connor, et al., 2016) which served as the evidence base for drafting its recommendations.

Additional information regarding harms/burdens of care and patient values and preferences for

care was derived from the professional literature and panel member experience.

Following recommendations from the Institute of Medicine (2011a) and the Grading of

Recommendations Assessment, Development and Evaluation (GRADE) working group (Guyatt

et al., 2011), the panel considered four factors as it drafted recommendations: 1) overall

strength of the evidence; 2) the balance of benefits vs. harms/burdens; 3) patient values and

preferences; and 4) applicability (generalizability across populations, interventions,

comparators, outcomes, timing, and settings). Based on the combination of these factors, the

panel made a strong or weak recommendation for or against the treatment or treatment strategy

or made a statement that there was insufficient evidence to be able to make a recommendation.

The panel used a Grid to document its decision-making process for each recommendation. A

copy of the Grid is available at

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(http://apacustomout.apa.org/commentPracGuidelines/Practice/Grid%20for%20Obesity%20GD

P%20Recommendations%20for%20posting.pdf).

Conclusion While the panel recommends family-based multicomponent interventions of 26 or more

contact hours, there was insufficient evidence for the panel to make recommendations

pertaining to specificity such as type of setting or provider, race and ethnicity of patients, and

socioeconomic status. Further, the panel only examined the outcome of BMI/zBMI, as that was

of critical interest and few other outcomes of interest (such as quality of life, change in emotional

functioning) were consistently reported; thus, other outcomes that might have resulted from the

intervention are not captured in this document. Health care providers are encouraged to help

facilitate awareness of childhood obesity among parents2, address barriers to treatment with

families, advocate for financial coverage of treatment, and to treat children and adolescents with

overweight or obesity and their parents in a non-stigmatizing/non-judgmental manner.

The recommendations in this guideline are similar to those of other health organizations.

However, the conclusion of the review, and subsequent agreement by the panel, that there was

insufficient evidence that setting, interventionist qualifications, mode of delivery, use of

multidisciplinary team including involvement of a psychologist, or cultural tailoring, in the

implementation of family-based multicomponent behavioral interventions, had independent

effects on standardized body mass index (zBMI) is a contribution to this arena, even if

disappointing regarding the insufficient evidence. There were several limitations identified in the

systematic review underlying this guideline. Limitations include a lack of information about the

amount of adiposity reduction needed in children and adolescents to improve certain other

aspects of health and the focus on only BMI as an outcome. It is possible that other outcomes

2 The panel recognizes that children live in many arrangements, typically with parents but sometimes with guardians or other carers. The panel generally uses parents for simplicity in the text but periodically adds other terms to underscore that appropriate adults may be engaged in care. Furthermore, the research literature regularly refers to “parental” behavior but again that is relevant to all adults raising children.

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could show improvement (e.g., diet quality, physical activity, and psychosocial outcomes).

Frequently, race and ethnicity as well as socioeconomic status data were not reported in

published studies, making it difficult to determine whether outcome disparities occur across SES

or race and ethnicity, which may be a particularly critical question given the significantly higher

prevalence of overweight and obesity among Hispanic and black youth. In addition, there was

insufficient information in the review to address two key questions (what is the impact of

selected strategies of family-based behavioral interventions in the management of age/sex-

standardized BMI and what is the effect of patient adherence, engagement, and retention on the

efficacy of intervention). There was also a lack of information on potential harms of

interventions, although behavioral interventions are generally viewed as not harmful.

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Clinical Practice Guideline for Multicomponent Behavioral Treatment of

Obesity and Overweight in Children and Adolescents: Current State of the

Evidence and Research Needs

from the Guideline Development Panel (GDP) for Obesity Treatment of the

American Psychological Association (APA)

Scope of the Guideline

The scope of this clinical practice guideline is on behavioral weight management for

children and adolescents aged 2-18 years with overweight or obesity as defined based on the

Centers for Disease Control and Prevention (CDC) BMI for Age and Gender growth charts.

Given recommendations provided by the US Preventive Services Task Force (USPSTF) in 2010

and 2017, and consistent with statements or guidelines from other health organizations (see

Appendix D), family-based, multicomponent behavioral interventions, including both diet and

physical activity or sedentary behavior (screen time) components, have shown the most

promise in improving weight status in children and adolescents with overweight or obesity.

Additionally, these programs are accepted as initial interventions due to the perceived

reluctance of families and providers to begin weight management with children and adolescents

with either medication or surgery, given the limited information about long term impact and

potential for adverse events. However, relatively little is known about the efficacy of specific

characteristics of these multicomponent interventions or their efficacy for different subgroups of

children and adolescents.

The panel considered the most recent systematic review in this area with a similar scope

(Janicke et al., 2014) and determined there was a need to update and expand the information

on efficacy studies. Earlier reviews and guidelines did not specify factors that may be important

for understanding how to successfully implement an intervention, who may benefit most from

2

intervention, what strategies are most efficacious, or areas of patient engagement needed for

successful outcomes. Therefore, to enhance understanding of clinical implementation of a

family-based, multicomponent behavioral intervention, the scope of this effort included an

examination of evidence including comparative effectiveness studies that would inform

implementation characteristics, child/family moderators, intervention strategies, and patient

engagement to provide recommendations important for clinical implementation of the

intervention. The panel commissioned Kaiser Permanente Research Affiliates Evidence-Based

Practice Center to conduct a systematic review of the evidence to address these questions and

based this guideline on that review (O’Connor, et al., 2016). The guideline does not address

other possible interventions. The intended users of this document include psychologists, other

health and mental health professionals, students/ training programs, consumers, families of

consumers, policy makers, and the public.

Summary of Recommendations of the APA GPD for the Treatment of Overweight and Obesity in Children and Adolescents

The panel recommends the following:

1. For child and adolescent patients aged 2-18 with overweight or obesity, the panel

strongly recommends the provision of family-based multicomponent behavioral

interventions, with a minimum of 26 contact hours, initiated at the earliest age possible.

The Panel was unable to make recommendations on the following:

1. There was insufficient evidence to determine the comparative effectiveness of selected

strategies of family-based multicomponent behavioral interventions, including goals and

planning, comparison of outcomes, self-monitoring of behavior, self-monitoring of

outcome, contingent reward or threat, stimulus control, modeling of healthy lifestyle

behaviors by parents, motivational interviewing, or parenting skills training.

3

2. There was insufficient evidence to determine whether specific intervention

characteristics or strategies were associated with adherence, engagement, or retention.

Higher attendance was associated with greater efficacy but there was insufficient

evidence to determine whether adherence (beyond attendance) was associated with

efficacy.

3. There was insufficient evidence to determine whether specific intervention strategies

were more effective with patients or families having specific characteristics. Other than

age, there was either no association or insufficient evidence3 to determine whether

population characteristics were associated with outcome.

Thus, providers have flexibility in selecting an efficacious family-based multicomponent

behavioral intervention program that addresses behavior change, diet and physical activity of

sufficient intensity with strategies used to accomplish change appropriate for particular patients

and local implementation needs.

Although there was no direct evidence to support a specific dietary intervention or

physical activity regimen over another, the findings support the use of family-based

multicomponent behavioral interventions that address behavior change, diet and physical

activity with sufficient intensity. These family-based behavioral treatments have several similar

key principles and strategies. Treatment focuses not solely on weight, but on overall health and

the development of healthful behaviors in the family. Treatments target changes in physical

activity, eating, and sedentary behaviors (energy-balance behaviors). Changes in weight and

zBMI are one measure of the success of these programs, but the focus is on overall changes in

energy-balance behaviors to improve health. These interventions follow a similar philosophy as

3 Participant race/ ethnicity, severity of adiposity and parental obesity status were not associated with outcome. There was insufficient evidence to determine whether socioeconomic status was associated with outcome.

4

general pediatric practices that educate parents about health behavior (e.g., eating habits,

physical activity, and sleep).

Importantly, the intervention is not solely provided to the child or adolescent; rather, the

intervention involves the parents and potentially other family members as active participants and

the level of their involvement relative to the child varies with the developmental age of the child.

The emphasis is on equipping caregivers with tools (problem-solving, providing contingent

rewards, etc.) that can be used to manage energy-balance behaviors4, and have relevance to a

myriad of other childhood issues. Both parents and children are targeted for increases in healthy

physical activity and eating behavior and decreases in sedentary behavior. Family-based

behavioral treatments typically do not promote extreme dietary restrictions but instead focus on

changes such as an increase in consumption of fruits and vegetables, and a decrease in

consumption of sugar-sweetened beverages to enhance diet quality. Activity changes may

include reducing the amount of time spent in screen-based behaviors, such as television

watching. Families learn how to focus on energy-balance behaviors in their actions and

conversations, rather than focus on weight as that can be stigmatizing and disheartening.

Practitioners have a fair amount of flexibility regarding the energy-balance behaviors when

tailoring specific elements to participating families taking into consideration such characteristics

as child gender, age, ability status and family culture.

These recommendations and this clinical practice guideline are not intended to set a

standard of care but rather to be a general guide to best practices. A clinical practice guideline

can facilitate decision-making for both provider and patient.

4 Energy-balance behaviors are the caloric intake/ ingestive behaviors balanced with the energy expenditure/ exercise/ physical activity behaviors that lead to whole body balance.

5

Table 1: Summary of Recommendations of the APA Guideline Development Panel for the Treatment of Obesity

Family-Based Multicomponent Interventions Strength of

Recommendation

For child and adolescent patients aged 2-18 with overweight or obesity, the panel strongly recommends that clinicians provide:

family-based multicomponent behavioral interventions with at least 26 contact hours initiated at the earliest age possible.

Strong For

Comparative Effectiveness of Components

For child and adolescent patients with overweight or obesity, the panel concludes that there is insufficient evidence to recommend for or against clinicians offering any selected strategies of family based multicomponent behavioral interventions over another, including:

goals and planning

comparison of outcomes

self-monitoring of behavior

self-monitoring of outcome

contingent reward or threat

stimulus control

modeling of healthy lifestyle behaviors by parents

motivational interviewing

parenting skills training

Insufficient

For child and adolescent patients with overweight or obesity, the panel concludes that there is insufficient evidence to determine if specific intervention characteristics or strategies are associated with adherence, engagement, or retention, or if adherence was associated with efficacy.

Insufficient

For child and adolescent patients with overweight or obesity, the panel concludes that there is insufficient evidence to determine whether specific intervention strategies were needed with patients or families having specific characteristics.

Insufficient

For child and adolescent patients with overweight or obesity, the panel concludes that there is either no association or insufficient evidence to determine whether other population characteristics other than age were associated with outcome.

Insufficient

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How these recommendations compare to recommendations in other obesity guideline

documents is addressed on pages 19-24.

People-first Language

Throughout the document the panel refers to the target population as “persons with

obesity” so as to separate the individual from the condition.

Introduction to the Topic

Overview of Problem, Healthcare Burden

Obesity in childhood is defined as body mass index (BMI) ≥ 95th percentile while

overweight is defined as BMI ≥ 85th percentile based on the CDC growth curves for age and

gender. Childhood obesity rates have increased in the United States in the past five decades. In

the 1960s the prevalence of obesity was approximately 4% in 6-11-year olds and 5% in those

12-19 years old; however, by 1994, the prevalence had increased to 11% for both age groups

(Ogden, 2002). As of 2014, 17% of youth (aged 2-19 years) had obesity (Ogden et al., 2016).

The prevalence of obesity increases with age. Preschool age children (2-5 years) have the

lowest prevalence at 9.4%, increasing to 17.4% for children 6-11 years old, and 20.6% for

adolescents (12-19 years) (Ogden et al., 2016). When including overweight statistics, 31.8 % of

youth (aged 2-19 years) have overweight or obesity (Ogden et al., 2014). Youth who met criteria

for severe obesity (BMI greater than or equal to 35 or 120% of the 95th percentile in weight,

Kelly et al., 2013) was 6% (Ogden et al., 2016).

In addition to differences by age group, there are also differences in obesity prevalence

by race and ethnicity. Overall, non-Hispanic white and Asian youth have a significantly lower

prevalence of obesity (14.7% and 8.6% respectively) compared to non-Hispanic black (19.5%)

and Hispanic youth (21.9%) (Ogden et al., 2015). The race and ethnicity pattern of obesity was

similar for female children, with Asian females having the lowest observed prevalence at 5.3%

compared to 15.1% for non-Hispanic white females, 20.7% for non-Hispanic black females and

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21.4% in Hispanic females (Ogden et al., 2015). For male children, Asians and non-Hispanic

whites have a lower rate of obesity (11.8% and 14.3% respectively) compared to non-Hispanic

black (18.4%) and Hispanic males (22.4%) (Ogden et al., 2015).5

Childhood obesity prevalence also varies based on the parents’ educational level and

socioeconomic status. For example, in a study of data from 1999-2010, the prevalence rates of

obesity among children with an adult head of household who completed college were nearly half

the rates (9% for females, 11% for males) as those with an adult head of household who did not

complete high school (19% for females, 21% for males) (May, Freedman, Sherry, & Blanck,

2013). In relation to household income, obesity prevalence typically has an inverse relationship

with income; however, this relationship is found more consistently in non-Hispanic whites

compared to non-Hispanic black and Hispanic youth (Freedman, Ogden, Flegal, Khan, Serdula,

& Dietz, 2007). However, while low income children and adolescents are more likely to have

obesity than their higher income counterparts, the relationship is not consistent across racial/

ethnic groups and it should be noted that most children and adolescents with obesity are not low

income.

The burden of obesity poses some immediate and longer-term health risks for children.

There are a number of immediate negative medical consequences due to obesity—many of

which increase as a function of the severity of obesity. These health effects include type 2

diabetes, hypertension, hyperlipidemia, asthma, polycystic ovarian syndrome, and nonalcoholic

fatty liver disease (Pulgaron, 2013) and an association with adult eating disorders (Hilbert et al.,

2014). In children, more severe obesity can lead to obstructive sleep apnea and

musculoskeletal/joint dysfunction (Bass & Eneli, 2015). In the longer term, children with obesity

have a higher probability of having obesity as adults, and many of the adult comorbid conditions

are more likely to occur with a prolonged history of obesity (Goldhaber-Fiebert, Rubinfield,

5 No data were reported for other racial/ ethnic groups, such as Native Americans.

8

Bhattacharya, Robinson, & Wise, 2013; Singh, Mulder, Twisk, Mechelen, & Chinapaw, 2008).

As children reach adolescence, an elevated BMI becomes increasingly predictive of risk of

obesity (BMI ≥ 30 kg/m2) in adulthood (Singh et al., 2008). For black and white males who have

a BMI at or above the 85th percentile (overweight) at the age of 15, 56.6% and 59.2%

respectively, are predicted to have obesity in their early 40’s. For black and white females who

have a BMI at or above the 85th percentile at the age of 15, the estimate is that 89.4% and

78.3%, respectively, are predicted to have obesity in their early 40’s (Goldhaber-Fiebert et al.,

2013). The higher probability of obesity in adulthood portends worse health outcomes later in

life. For instance, it is estimated that over the next 40 years, those younger than 20 years old

with obesity may experience an increase in the prevalence of type 2 diabetes of 49%

(Imperatore et al., 2012).

Obesity can also have deleterious effects on mental health and psychosocial

development in children. Compared to children who have a healthy weight, those with obesity

have higher rates of depression, social isolation, low self-esteem, and poorer quality of life

(Small & Aplasca, 2016). Weight-based stigmatization may play an important role in these

outcomes. Children with overweight or obesity experience pervasive and often unrelenting

weight stigmatization from an early age (Puhl & Latner, 2007; Harrist, Swindle, Hubbs-Tait,

Topham, Shriver, & Page, 2016). Indeed, weight-based bullying is more prevalent than bullying

based on race, sexual orientation and religion (Puhl, Latner, O’Brien, Luedicke, Forhan, &

Danielsdottir, 2016). Overweight youth experience significantly more bullying than their peers

who are of a healthy weight (Van Geel et al., 2014), with the severity of bullying and

stigmatization increasing as weight increases (Puhl, Luedicke, & Grilo, 2013). Sources of

stigmatization include peers, parents, teachers, coaches and strangers (Puhl et al., 2013).

Weight stigmatization can take many forms, including teasing, ignoring, excluding, or rejecting

the individual; and physical or verbal harassment (Harrist et al., 2016; Schvey, Puhl, & Brownell,

2011). Although childhood obesity has become far more commonplace, weight based

9

stigmatization remains pervasive (Lumeng, Forrest, Appugliese, Kaciroti, Corwyn, & Bradley,

2010). Given the immediate health and psychosocial consequences, as well as the increased

long-term health risks in adulthood associated with overweight and obesity during childhood,

addressing overweight and obesity during childhood has important positive health implications

(Pulgaron, 2013).

Current Guidelines for Treatment of Childhood Obesity

The need for evidence-based recommendations for the treatment of overweight and

obesity in children and adolescents has been recognized for over two decades. In 1997, the

Department of Health and Human Services Health Resources and Service Administration

convened an expert committee to develop recommendations on the assessment and treatment

of childhood obesity (Barlow & Dietz, 1998). However, their recommendations, published in

1998, were predominantly developed from consensus reached by the expert committee, with

few, if any, of the recommendations for assessment and intervention being based on a

systematic review of evidence, due to a lack of published research in the area.

In 2005, the American Medical Association (AMA), the Health Resources and Service

Administration (HRSA), and the CDC convened a new expert committee so that new

recommendations could be developed for childhood obesity (Barlow, 2007). As the research

base in the area of childhood obesity had expanded, the committee relied primarily on research

evidence but, where evidence was lacking, also relied on clinical experience to provide

practitioners with practical guidance for the treatment of obesity in childhood. While the

recommendations were developed mostly from research, a systematic review was not

conducted to inform the guideline. Instead, the writing groups of the committee broadly rated the

evidence as being consistent, mixed, or suggestive. Furthermore, the recommendations

covered all areas of care for childhood obesity. Thus, when evidence in a considered area was

lacking, the writing groups took into account extant literature, clinical experience, other health

benefits and harms, and feasibility of implementation in making the recommendations.

10

This guideline, published in 2007, proposes a staged-approach to treatment (Spear,

Barlow, Ervin, Ludwig, Saelens, Schetzina, & Taveras, 2007). The authors of the report

acknowledged that while the components of the stages may be supported by evidence, the

staged-approach had not been evaluated, and therefore the staged aspect is not evidence-

based. This approach contains four stages: 1) Prevention Plus (healthy lifestyle changes), 2)

structured weight management, 3) comprehensive multidisciplinary intervention, and 4) tertiary

care intervention. The stages are recommended to be implemented in children starting at the

age of two years, when the BMI is > 85th percentile. Prevention Plus starts with recommending

changes in a few dietary (e.g., increase fruits and vegetables, decrease sugar sweetened

beverages), physical activity, and/or screen-based (e.g., television watching) behaviors;

incorporating the family into making these changes; using behavioral strategies in support of the

changes; and having monthly assessments. Each sequential stage is to be implemented if the

child’s weight status does not improve after 3 to 6 months of active treatment at the current

stage. The intervention increases in intensity through the stages in five ways: 1) enhanced

dietary structure; 2) greater use of a broader range of behavioral strategies for assisting with

changing diet, activity, and screen-based behaviors; 3) increased frequency of contact; 4)

greater use of specialists trained in the intervention, as well as the use of professionals from

across multiple disciplines; and 5) the addition of medication and/or surgery to the intervention.

When the second expert committee was convened in 2005, the USPSTF had just

published a systematic review (Whitlock, Williams, Gold, Smith, & Shipman, 2005) on screening

and interventions for childhood overweight, which found insufficient evidence to recommend for

or against routine primary care screening for overweight in children and adolescents (an “I”

recommendation) (USPSTF, 2005). This rating was due to the finding that the efficacy of

behavioral counseling or other primary care–relevant interventions in childhood obesity was not

clear. In 2010, the USPSTF updated its systematic review and examined primary care–relevant

behavioral and pharmacologic weight management interventions for children aged 2 to 18 years

11

who had overweight or obesity. Behaviorally-based interventions were defined as interventions

that targeted changes in diet and/or physical activity, often involved parents or the entire family,

and included cognitive and behavioral techniques to assist with changing diet and activity

(Whitlock, O’Connor, Williams, Beil, & Lutz, 2010). Pharmacological interventions were

considered adjunctive interventions to behaviorally-based interventions, but only for adolescents

with severe obesity. Bariatric surgery as an intervention was considered out of the scope of the

review.

Results of the systematic review found that the available research had been conducted

in children aged 4 to 18 years, with no study implemented in children under the age of 4 years

(Whitlock et al., 2010). Comprehensive behavioral interventions that included a diet and activity

focus, involved the family, and used behavioral strategies with contact time of 26 to 75 hours

were the most efficacious approach, with weight improvements at 12 months favoring

behavioral intervention. Two medications used as adjunctive therapy to behaviorally-based

interventions found small (orlistat) or moderate (sibutramine) improvements in weight status in

adolescents who had obesity and only when on active medication. Based on the results of the

review, the USPSTF recommended that clinicians screen children aged 6 to 18 years for obesity

and offer or refer these children to intensive counseling and behavioral interventions to promote

improvements in weight status (grade B recommendation) (USPSTF, 2010) and re-confirmed

that recommendation in 2017 (USPSTF, 2017). These recommendations were endorsed by the

American Academy of Family Physicians (AAFP, 2014).

Several other health organizations have published recommendations for weight

management in children and adolescents with overweight or obesity. The American Heart

Association (AHA) in 2005 recommended five guiding principles for treating children who are

overweight. These were: 1) establishing an age and comorbidity appropriate treatment plan, 2)

involving the family, 3) frequent assessment and monitoring, 4) considering other behavioral,

psychological, and social correlates, and 5) recommending change in diet and increase in

12

physical activity within the family environment (Daniels et al., 2005). In 2013, the AHA

recognized limitations of initial lifestyle modifications and pharmacotherapy for children and

adolescents with severe obesity and recommended bariatric surgery as the most efficacious

treatment for severe obesity in adolescents (Kelly et al., 2013). The 2013 AHA

recommendations were endorsed by The Obesity Society.

Also in 2013, two other organizations published their own statements. The Academy of

Nutrition and Dietetics recommended comprehensive interventions for weight management in

children and adolescents (Hoelscher, Kirk, Ritchie, & Cunningham-Sabo, 2013). The

recommended interventions include the following components: 1) change in diet, 2) increase in

physical activity, 3) behavioral counseling, and 4) parental/caregiver involvement. Active

participation of parents/caregivers was deemed necessary for 2- to 5-year-old children along

with monitoring of weight status. More intensive therapies, including pharmacotherapy or

bariatric surgery were to be considered for children older than 6 years, after more intensive

evaluation (Hoelscher et al., 2013). The National Institute for Health and Care Excellence

(NICE) has recommendations for lifestyle weight management programs. Broadly, NICE (2013)

recommended that all such programs be multicomponent and focused on diet and healthy

eating habits, increase in physical activity and reduction in sedentary time, and behavior

modification techniques in support of the children or adolescents, along with their families. Other

earlier expert statements also focused on multicomponent interventions targeting diet, physical

activity, sedentary behavior, and behavioral components in a family context. These include

those published by the National Heart, Lung, and Blood Institute (NHLBI) Expert Panel (2011)

and by the Endocrine Society (2008).

While the strength of the evidence in support of the recommendations proposed by

these health organizations is variable, a common consensus is the requirement that

interventions for the management of weight in children and adolescents with overweight or

obesity include four key components. These components are: following a healthy diet,

13

increasing physical activity and/or reducing sedentary time, incorporating behavioral practices in

support of the required changes in behavior, and parental involvement. Involvement of parents

or caretakers is considered important, particularly for young children.

The panel reviewed some existing systematic reviews that examined the efficacy of

surgery for adolescents (See Appendix E). While the panel did not conduct an exhaustive

review of the literature in this domain, several reviews were identified. Three reviews examined

reduction in weight or BMI outcomes (Ells et al., 2015; Paulus, DeVaan, Verdam, Bouvy,

Ambergen, & Van Heurn, 2015; and Willcox & Brennan, 2014) while two reviews examined

psychosocial outcomes of bariatric surgery (Herget, Rudolph, Hilbert, & Bluher, 2014 and

Willcox & Brennan, 2014). The reviews did find that adolescents experienced substantial weight

loss post-surgery with an “acceptable complication rate”6 (Paulus, 2015, p. 860). Additionally,

Herget et al. (2014) found that levels of depressive symptoms improved post-operatively and

Willcox and Brennan (2014) found evidence for resolution of medical comorbidities but limited

reporting of psychosocial outcomes. However, most reviews noted that surgery is typically

considered only after attempts at lifestyle modification, consistent with recommendations from

existing guidelines such as the recent document from the Endocrine Society (Styne, Arslanian,

Connor, Farooqi, Murad, Silverstein, & Yanovski, 2017).

Methods and Process

Vetting and Appointment of Members to the Obesity GDP. The Advisory Steering

Committee (ASC) put out a call for the nomination (including self-nomination) of both

6 Three surgeries were reviewed (laparascopic adjustable gastric band, Roux-en-Y gastric bypass, laparscopic sleeve gastrectomy) in a total of 37 studies. Perioperative complications occurred in 1-2% of surgeries. Up to 6% experienced infection at the surgical site. Depending on surgery, 5-10% of patients had gastrointestinal complaints (nausea, vomiting, GERD, diarrhea and gallstones) post surgery. Post LAGB, 14.7% had additional surgeries such as replacement, repositioning or removal of the band. Late complications, such as obstruction, ulcers and abdominal wall hernias, occurred in 20% of RYGB patients.

14

researchers and clinicians across various professional disciplines (psychology, social work,

psychiatry, general medicine) who had content expertise in the topic area of obesity treatment

as well as in biostatistics or methodology. The ASC sought those with knowledge of obesity

across age groups, sex, populations and treatment settings in order to seat a diverse panel with

a variety of perspectives on obesity and its treatment that could discuss the research evidence

and its applicability to those seeking treatment. Treatment developers who might have a strong

allegiance to their particular method were not selected to serve on the guideline development

panel (GDP) by the ASC, but their participation in the public comment period was encouraged.

Additionally, community members, self-identified as having had obesity (currently or in the past),

who were active in the leadership of groups that sought to enhance public awareness and

access to services, were sought.

Conflicts of interest. Before final appointment to the GDP, nominees provided

information regarding possible conflicts of interest, a significant issue in the AHRQ and IOM

standards. Conflicts of interest (COI) are defined as, “a divergence between an individual’s

private interests and his or her professional obligations such that an independent observer

might reasonably question whether the individual’s professional actions or decisions are

motivated by personal gain, such as financial, academic advancement, clinical revenue

streams, or community standing” (IOM, 2011; Schünemann et al., 2009). The IOM report

additionally discusses intellectual COIs relevant to clinical practice guidelines, which are defined

as “academic activities that create the potential for an attachment to a specific point of view that

could unduly affect an individual’s judgment about a specific recommendation” (IOM, 2011;

Guyatt et al., 2010).

Candidates to the GDP each completed an APA COI form. Emphasis was placed on

their disclosing all potential conflicts for the APA staff and ASC members to review and decide

upon. While intellectual affiliations were expected, panel members were not to be singularly

identified with particular interventions nor were they to have significant known financial conflicts

15

that would compromise their ability (or appearance thereof) to weigh evidence fairly. It was

understood however that some “adversarial collaboration” representing different points of view

was to be expected and encouraged as part of the process. Upon successful completion of the

reviews, the ASC made the final membership recommendations to the APA Board of Directors

for confirmation.

Once the panel was formed, all members completed an educational module on COI that

underscored the importance of identifying and managing any COI that had either been identified

or that might come to light. Members were asked to verbalize any actual or potential conflicts in

their face-to-face meetings, so all members of the GDP would be familiar with the diversity of

perspectives and range of possible influences and biases. COI forms were updated on an

annual basis and panel members and staff were asked to provide more timely updates if there

was any change in their disclosures that could be relevant to the development of an unbiased

guideline. The APA COI policy and disclosure form can be found in Appendix B.

Scoping and Key Questions. The panel engaged in preliminary discussion of topic

scoping at its first in-person meeting and then continued this discussion over a series of

conference calls. The panel used a “PICOTS” (Population, Intervention, Comparator, Outcomes,

Timing, and Setting) approach to scoping. With this approach, the panel used each of these

elements as a framework to guide decisions about scope. Two tools were used to facilitate the

scoping discussion: a review of existing guidelines and reviews on obesity identified by Kaiser

Permanente Research Affiliates scientists and a survey that the panel used in order to rate the

priority of various outcomes. Based on the existence of a recently released guideline focusing

on treatment of obesity in adults (AHA/ACC/TOS, 2013), the panel decided to focus its work on

children and adolescents. Based on the outcome prioritization survey in which panel members

rated outcomes from 1 “not important” to 9 “critical” for making a decision about what treatment

to recommend the panel decided to focus on BMI/ zBMI and serious adverse events as the

most critical outcomes.

16

A Body Mass Index (BMI) is a measure of body fat adjusted for height and is calculated

by weight in kilograms divided by the square of the height in meters (kg/m2). A BMI is

considered an indirect measure of body fat that is meant to screen for overweight or obesity. In

children it is recommended that a BMI be calculated and plotted on the CDC BMI-for-age and

sex specific growth curve at a minimum annually. A BMI could also be standardized (zBMI) so

that each score represents an individual’s standing relative to his or her specific age and sex

group. Elevated BMI levels correlate with an individual’s excess body fat, health risks such as

cardiovascular risk factors, and prediction of future adiposity (Barlow, 2007).

When determining a child’s risk for overweight or obesity, clinicians consider the child’s

BMI trajectory, growth curve, body fat distribution, diet and activity habits, familial obesity or

predisposition to obesity, child and family medical risks, and, if appropriate, laboratory tests

(Barlow, 2007). Benefits of a BMI include ease of obtaining and calculating, cost-effectiveness,

ability to use in a clinical environment and patient and provider familiarity with the measure

(Styne 2017, CDC 2015). A BMI has limitations on its precision, as it cannot differentiate

muscle from adipose tissue. However, a BMI has demonstrated acceptable clinical validity and

can guide weight management in children (Barlow, 2007, Styne 2017).

The guideline used zBMI as the index of overweight or obesity when available. Thus, in

addition to accounting for height (and, therefore, growth), it also accounts for age and sex.

zBMI is a relative not an absolute measure. As used in the systematic review and the guideline,

it provided a metric commonly used across interventions and age groups that allowed relative

comparisons of efficacy and effectiveness.

Scoping decisions about which populations, interventions, comparators, outcomes,

timing, and settings to include were as follows (O’Connor et al., 2016; p. A-17):

17

Category Include Exclude Condition Definition

Studies identifying children [with] overweight or obesity according to sex- and age-specific criteria using methods such as BMI, BMI percentile, BMI z-score, or weight adjusted for height (percent ideal weight, percent overweight).

Studies using waist circumference, skin fold, bioimpedance, or other adiposity measures without also using age/sex-specific BMI measures.

Aim Studies that include a weight reduction focus (primary aim may be targeting a comorbidity using weight reduction).

Population Age 2-18 years Either: (a) the entire sample has an age- and sex-specific BMI ≥ 85th percentile or meets other similar criteria for overweight based on ideal body weight, or (b) ≥ 50% of the sample has an age- and sex-specific BMI ≥ 85th percentile and ≥ 80% have risk factors for overweight (e.g., children of overweight parents; Hispanic, Black, or American Indian/Alaska Native ethnicity) or obesity-related medical problems (e.g., diabetes, metabolic syndrome, hypertension, lipid abnormalities, or other cardiovascular-related disorders).

Average age < 2 years or > 18 years

…Youth who: (1) have an eating disorder, (2) are pregnant or postpartum, (3) [have] overweight or obesity secondary to a genetic or medical condition (e.g., polycystic ovarian syndrome, hypothyroidism, Cushing’s Syndrome, growth hormone deficiency, insulinoma, hypothalamic disorders (e.g., Froelich’s syndrome), Bardet-Biedl syndrome, Prader-Willi syndrome) or medication use (e.g., antipsychotics), (4) are in college

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Category Include Exclude Intervention Behavioral interventions that involve

parents or caregivers in some way and include a minimum of 3 components:

o Focus on increase in physical activity or decrease in sedentary behavior

o Focus on dietary change o Behavioral component in

support of 1 and/or 2 May include complementary and

alternative medicine approaches if 3 minimum components above are present

Intervention may target parents alone or in combination with the child

Mode of delivery must involve an interventionist and may include individual, group, family, multidisciplinary, internet, telephone, mailings, social media

Primary prevention in normal weight children

Pharmacological interventions Surgical interventions Self-help intervention (must be

interventionist) Provides all or most of

participants’ food

Comparator Any comparison of behaviorally-based components Agreed on 2-step approach. Efficacy studies were examined as a first step, followed by examination of only those comparative effectiveness studies that involve interventions that were found to be efficacious in the first step.

Active comparator if no efficacy established through review. [If the efficacy of an intervention could not be established first via the systematic review, it was not included as an active comparator (i.e., for comparative effectiveness).]

Outcomes Studies must report BMI or weight adjusted for height or a similar measure (e.g. age- and sex-specific zBMI, BMI percentile, percent overweight)

Population changes in BMI or other adiposity measures in mixed primary prevention (normal weight) and populations that are overweight or have obesity.

Timing of Outcome Assessment

Outcomes assessed at or after 12 months post initial assessment and total duration of intervention.

Setting All outpatient settings (e.g., primary care, clinic, psychological services center, community, after school, virtual [technologically-delivered]).

Residential/Inpatient Classroom-based [These settings were excluded to meet constraints for the time and budget to complete systematic review.]

Study Design

[Randomized controlled trials] RCT, [Controlled clinical trials] CCT. [Trial that includes a control group comparison.]

All other study designs.

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Category Include Exclude Country Economically developed countries,

defined as OECD member countries: Australia, Austria, Belgium, Canada, Chile, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, Korea, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States.

Non-OECD member countries.

Publication Type

Peer-reviewed manuscripts and reports.(We tested for publication bias where there was an adequate number of studies for the statistical test or plotting approach.)

Non-peer-reviewed publications, book chapters, editorials, letters, non-systematic reviews, opinions, meeting abstracts

Language English. Languages other than English.Publication Date

1985 – 2016 [Reflecting dates of earlier incorporated systematic reviews as well as updated bridge searches.]

Study Quality

Fair or good, according to design-specific criteria.7

Poor, according to design-specific criteria.

Abbreviations: BMI = body mass index; CCT = clinical controlled trial; e.g. = for example; OECD = Organization of Economic Cooperation and Development; RCT = randomized controlled trial; USPSTF = U.S. Preventive Services Task Force

The five key questions identified by the panel were noted at the beginning of the document and

in the key questions section below.

Comprehensive Search of the Professional Literature. As the name implies, a systematic

review involves a methodical and organized search for studies and evidence of efficacy (and

comparative effectiveness) regarding the treatment under consideration (IOM, 2011b). The

panel considered available systematic reviews and deemed no existing review met the criteria

consistent with its key questions. Thus, the panel decided to commission a new systematic

review, which was conducted by the Kaiser Permanente Research Affiliates EPC (O’Connor et

al., 2016). For the systematic review, a variety of scientific databases were searched using

7 See Harris et al. 2001 for details regarding evaluation of study design and quality with particular emphasis on internal validity.

20

selective search terms to identify relevant studies. The list of search terms is too extensive to

include in this document but can be found in Appendix A (pp. A1 – A15) of the systematic

review. The identified individual studies were then assessed to determine whether they met

inclusion criteria (e.g., were aged 2-18) and rated, using pre-defined criteria, to establish quality.

Studies were included if they met inclusion criteria and were randomized controlled trials (RCTs)

or non-randomized controlled clinical trials (CCTs) that were of fair or good quality. Quality was

rated based on criteria from the U.S. Preventive Services Task Force (USPSTF). Please see

A17- A18 and page A19 in Appendix A of the systematic review for details of the

inclusion/exclusion criteria and of the quality rating criteria respectively. A diagram on page A16

of Appendix A in the systematic review (O’Connor et al., 2016) shows the disposition of articles

excluded and included in the systematic review. In brief, after an exhaustive search strategy,

screening of 9,491 records, review by researchers of the full-text of 577 articles, 119 articles (65

studies [i.e., more than one published article resulted from some studies]) were included in the

systematic review.

The Development of Evidence Tables. Evidence tables (summaries of data in available

studies) were created by the Kaiser Permanente scientists from evidence collected for the

systematic review regarding the efficacy or comparative effectiveness of treatments. These

tables contain the foundational evidence on which current recommendations were made and

generated some of the information included in the Grid (described below). The evidence tables

(please see Appendix D of the Kaiser Systematic Review (O’Connor, et al., 2016)) were

abstracts of data included in the systematic review and include, as available for each body of

evidence, the number of studies, effect sizes, confidence intervals (when available) and quality

ratings.

The Development and Use of the Grid. The Grid was a document developed and used

by panel members to summarize and evaluate the evidence generated in the systematic review,

along with any supplemental information. Panel ratings and judgments were documented on the

21

Grid to assist in the formulation of recommendations. This Grid allowed panel members to

document decisions, compare consistency across decisions, and provide transparency to

reviewers and users of the guideline document. Decisions were documented in four main

domains: 1) strength of evidence; 2) the balance of benefits vs. harms/ burdens of interventions;

3) patient values and preferences; and, 4) applicability of the evidence to various treatment

populations. The Grid

(http://apacustomout.apa.org/commentPracGuidelines/Practice/Grid%20for%20Obesity%20GD

P%20Recommendations%20for%20posting.pdf) was comprised of distinct columns for separate

key questions to allow decision-making by key question. However, it was formatted to allow

consideration of the same data for harms and burdens across those columns/key questions.

Although some have questioned the applicability of some randomized trials due to

potential differences between sample characteristics or treatment settings and the “real world,”

the panel decided to not supplement the randomized trials included in the systematic reviews

(SRs) with observational (i.e., non-randomized and less methodological rigorous) treatment

studies, due to the potential for confounding bias in observational studies (Fewell, Smith, &

Sterne, 2007; Rothman, Greenland, & Lash, 2008). This decision is consistent with the position

of all major organizations that evaluate research and conduct systematic reviews, including

GRADE, Cochrane, NICE, AHRQ Evidence-Based Practice Centers, that randomized trials

have lower potential for bias than observational studies (Guyatt et al., 2011; NICE, 2012;

Reeves et al., 2011; Viswanathan et al., 2012).

Panel members made two significant exceptions to this decision when it became clear

that data were lacking in randomized trials regarding two outcomes: 1) harms and burdens of

psychosocial treatments, and 2) patient values and preferences with regard to particular

treatments. In response, the panel determined there was a need to gather and review additional

information on these topics. Concerning harms, panel members decided to review those

observational studies that gave attention to the assessment of harms that were identified in the

22

systematic reviews. It also authorized APA staff assigned to the GDP to compile information on

possible harms and burdens of interventions as well as patient values and preferences from an

additional review of the literature. Concerning patient values and preferences, the panel

considered data from the search of the literature conducted by APA staff and information from

consumer and clinician members of the panel. Details of the search process methodology for

both of these supplemental sources of information are described below. The findings of these

additional reviews along with input from clinicians and consumers on the panel were used to

make the treatment recommendations more comprehensive with regard to the risk of harm or

adverse events associated with treatment for overweight or obesity, and patient values and

preferences.

Each panel member was given an explicit opportunity to raise any questions or concerns

about how the Grid was completed. The panel reviewed the Grid to identify any questions or

concerns that audiences of the guideline (including patients, clinicians, and scientists) might

raise. For purposes of consistency across all CPG, the ASC established voting procedures that

can be found in Appendix C.

These four domains of information (overall strength of the evidence, balance of benefits

vs. harms, patient values and preferences, and applicability) constituted the basis on which

each treatment recommendation and its strength was determined. For each recommendation,

text description and a justification for the recommendation were included on the Grid.

Rating of Aggregate/Global Strength of Evidence (SOE). For each column of the Grid

(which corresponds to a question of interest), aggregate/global SOE was based on the SOE

from the systematic review for the two critical outcomes; namely, response to treatment

(measured as BMI/zBMI as an absolute response, as well as a response of ≥ -0.25 zBMI, which

may provide significant improvements in cardiometabolic health in children) and serious adverse

events. In accordance with the GRADE consortium system, the panel adhered to the rule that

the aggregate SOE could be no higher than the lowest individual SOE for each of the critical

23

outcomes (Guyatt et al 2013). For example, if one critical outcome had ‘high’ strength of

evidence but the other critical outcome had ‘low’ strength of evidence, the global quality of

evidence for that particular column in the Grid would be ‘low,’ since that is the lowest SOE for an

individual critical outcome. The strength of evidence for serious adverse events, one of the

panel’s critical outcomes, was insufficient/very low, for all interventions for which Grid columns

were completed. This explains why the global strength of evidence was insufficient/very low for

all interventions, despite low, moderate or high strength of evidence for the critical outcome of

BMI/zBMI. Thus, the application of the rule of aggregate strength of evidence is a limitation in

the case of behavioral interventions where reporting of serious adverse events is limited yet the

harms are considered minimal. The panel rated each component separately to highlight the

higher strength of evidence for BMI/zBMI.

Assessing Magnitude of Benefits. One of the key components of the decision-making

process for the GDP was assessment of the balance between benefits and harms. This required

that both benefits and harms be quantified. This section describes the methods used to quantify

the magnitude (size) of benefits.

Quantification of benefits was based on data from the quantitative meta-analyses for

each column of the Grid. Magnitude of benefits was rated as large, medium, or small benefit of

treatment or no difference in effect or unable to rate.

Assessing Magnitude of Harms/Burdens. Since “serious adverse events” was one of the

two critical outcomes of treatment decided upon by the panel, these needed more precise

specification and definition. Ultimately, panel members defined events such as medical

problems (e.g., stunted growth) as a serious adverse event. Harms were differentiated from

burdens with harms being negative events resulting from treatment (e.g., symptom worsening)

and burdens were identified as disruptions associated with treatment (e.g., time spent,

convenience). As discussed earlier, the systematic review of the treatment literature did not

24

generate sufficient data on harms and burdens of interventions because this information is not

routinely reported in studies.

In response to this deficit, the panel commissioned APA staff to examine articles in the

systematic review to extract data regarding harms and burdens, such as dropout/attrition,

symptom worsening, etc. All included trials were reviewed for harms and burdens. Four hundred

fifty-eight excluded articles are listed in Appendix B. To reduce this number and to be consistent

with methodology utilized with previous CPG panels, excluded articles that were either: (1) not

an RCT/CCT and (2) reported high dropout and attrition OR had some other quality issue or not

enough information to assess quality were identified, resulting in 93 articles (all other excluded

articles did not satisfy other inclusion criteria such as type of intervention, population, etc.).

Forty-one of these 93 articles were freely accessible on the internet or through existing library

resources (no requests were made to the librarian to locate full text of missing articles). Twenty-

five of the studies provided usable data. The other 16 articles included commentaries, study

protocols, or secondary analyses of primary trials and as such were not included in analyses of

harms and burdens. Information regarding harms and burdens contained in these excluded

studies was examined because doing so is acceptable under the IOM standards, which allow

more relaxed criteria when examining literature on harms/burdens (Institute of Medicine, 2011b,

p. 8). No additional literature searches were conducted.

It was from these studies that the panel had additional information on possible harms or

burdens associated with the interventions under consideration. All of this evidence was rated

insufficient/very low strength of evidence due to inclusion of observational study designs, which

have a higher risk of bias than randomized trials.

Finally, to supplement the limited information on harms and burdens gleaned from

published research, clinicians on the panel reported their experiences in delivering, supervising

or training in particular interventions and the concerns noted by colleagues. The community

member reported on both her own and peer experiences with various interventions. Though it

25

was important to obtain all available sources of information on harms and burdens, due to the

inclusion of both anecdotal (i.e., clinician and community member report) and peer reviewed

article information, the Strength of Evidence on these topics was considered insufficient/very

low. Magnitude of harms/burdens was rated as large, medium, small, or no harm/burden of

treatment or unable to rate.

Once possible harms and burdens were identified, panel members then compared these

with the benefits of the interventions. On the Grid, the panel rated whether the balance of

benefits to harms/burdens strongly or slightly favors Treatment 1 over Treatment 2/control or the

reverse, if the balance of benefits to harms/burdens was the same, or if the panel was unable to

determine the balance of benefits to harms/burdens between Treatment 1 and Treatment

2/control.

Assessing Patient Values and Preferences. In addition to assessing the benefits and the

harms/burdens associated with specific interventions, the panel attempted to ascertain patient

values and preferences. As described above, to ascertain this information, the panel relied on a

search of the literature as well as clinicians and consumers on the panel who voiced their

perspectives about preferences for different interventions as well as the value that patients

might place on different outcomes or harms/burdens associated with particular treatments. The

SOE for all of this information was very low because it included observational studies and

“expert” (i.e., panel member) opinion.

Applicability of Evidence. The final determinant that panel members considered, before

making recommendations, was the applicability (generalizability) of the evidence to various

populations and settings. To organize information on applicability, panel members applied the

PICOTS framework (referring to Populations, Interventions, Comparators, Outcomes, Time and

Settings; Samson & Schoelles, 2012). The panel reviewed specific information from the studies

to determine if there were any concerns pertinent to applicability pertaining to population,

26

interventions, comparators, outcomes, timing, or settings needed to be included and noted on

the Grid.

Decision-Making Regarding Treatment Recommendations. On the basis of the ratings of

these four factors (strength of evidence, balance of benefits versus harms/burdens, patient

values and preferences, and applicability) the panel then made a decision regarding its

recommendation for a particular treatment or comparison of treatments. The options included a

strong (“the panel recommends”) or conditional (“the panel suggests”) recommendation either in

support of or against a particular treatment on the basis of the combination of these factors.

Panel members could also decide that there was insufficient evidence to be able to make a

recommendation about a particular treatment. Panel members were able to reach consensus

regarding the strength of each recommendation.

External Review Process. This document was submitted to the ASC for feedback. The

ASC comments were given a detailed review and response, and the document was modified

based on that feedback. The document was posted on the APA web site and public feedback

was solicited for 60 days. Panel members reviewed all comments and further revised the

document. Detailed responses to public comments will be made available upon request.

Recommendations and Statement of Evidence

Of the 65 included trials, 36 were “efficacy trials” that evaluated the family-based

multicomponent behavioral intervention against a control group. Two trials were maintenance

only interventions (“maintenance trials”) that participants engaged in after finishing the weight

reduction intervention. Thirty-four of the trials were classified as “comparative effectiveness” due

to including at least two active intervention arms. However, six of these were also classified as

efficacy trials due to including a control group. See Table 2 for details of effect sizes.

27

Recommendation:

For child and adolescent patients aged 2-18 with overweight or obesity, the panel

strongly recommends the provision of family-based multicomponent behavioral

interventions, with a minimum of 26 contact hours, initiated at the earliest age possible.

Statement of evidence rationale:

Out of 36 efficacy trials for children or adolescents with overweight or obesity, family-

based multicomponent behavioral interventions showed an average reduction of -

0.16 zBMI (95% confidence interval: -0.24 to -0.07) relative to non-active controls.

Out of 40 efficacy and comparative effectiveness trials for children or adolescents

with overweight or obesity, family-based multicomponent behavioral interventions

achieved a zBMI reduction greater than or equal to -0.25 in 37.5% of the trials.

These 40 efficacy and comparative effectiveness trials provided moderate quality

evidence of a small effect.

Two trials provided low quality evidence of no maintenance effect.

Out of 12 efficacy trials for children or adolescents with overweight or obesity, family-

based multicomponent behavioral interventions with 26 or more contact hours

showed an average reduction of -.27 zBMI (95% confidence interval -0.38- -.16)

relative to non-active controls.

Out of 24 efficacy and comparative effectiveness trials for children or adolescents

with overweight or obesity, family-based multicomponent behavioral interventions

with 26 or more contact hours achieved a zBMI reduction greater than or equal to -

0.25 in 58.3% of the trials. These 12 efficacy trials provided moderate quality and

these 12 comparative effectiveness trials provided low quality evidence of a medium

effect.

28

Out of 13 efficacy trials for children or adolescents with overweight or obesity, family-

based multicomponent behavioral interventions with less than 26 contact hours

showed an average reduction in zBMI of -0.04 (95% CI -0.10 to 0.01).

Out of 16 efficacy and comparative effectiveness trials for children or adolescents

with overweight or obesity, family-based multicomponent behavioral interventions

with less than 26 contact hours, only one trial achieved a zBMI reduction greater

than or equal to -0.25, which was 6.2% of the trials. These trials provided moderate

quality evidence of no effect.

Out of 25 efficacy or comparative effectiveness8 trials for children or adolescents with

overweight or obesity using family based multicomponent behavioral interventions

with 26 or more hours of contact, there was a significant association (p = 0.03)

between age and whether the trial met the clinically significant reduction in zBMI

greater than 0.25.

Among the 14 trials showing a clinically significant reduction, 10 (71%) targeted

preschool or elementary aged children. All trials targeting preschool children showed

a benefit.

Of the trials that did not show a benefit, 3 (27%) targeted elementary school age

children, and 4 (36%) targeted adolescents. These trials provided low quality

evidence that the effect is stronger when intervening with young children.

Beyond the number of contact hours, neither the number of sessions nor the length

of treatment was related to efficacy of treatment.

There was no evidence that other selected characteristics of family-based

multicomponent behavioral interventions, including setting, interventionist

8 This includes one comparative effectiveness trial that was a maintenance trial.

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qualifications, mode of delivery, use of multidisciplinary team including involvement

of a psychologist, or cultural tailoring, had independent effects on zBMI.

Recommendation:

There was no association to suggest severity of adiposity, parental obesity, race or

ethnicity, and insufficient evidence to suggest socioeconomic status made a difference in

the outcome of high intensity family based multicomponent behavioral interventions.

Statement of evidence rationale:

Out of 36 efficacy trials for children or adolescents with overweight or obesity using

family based multicomponent behavioral interventions with 26 or more hours of

contact, the following characteristics: child’s age categorized as preschool (age 2 to

6 years), elementary (aged 6 to 12 years), or adolescent (age 12 to 18 years); target

children who are overweight; required at least one parent to have overweight or

obesity; or 50% or more Black or Hispanic, showed nonsignificant effect modification

on zBMI (ps 0.22 to 0.98) in meta-regression. These trials provided low quality

evidence of no effect modification.

Evidence was insufficient to evaluate socioeconomic status, as only 2 efficacy trials

targeted participants of low socioeconomic status.

There was a significant association (p = 0.03) between race/ethnicity and whether

the trial met the clinically significant reduction in zBMI greater than 0.25. None of the

four trials with 50% or more of black and Latino children met criterion for clinical

significance. However, none of these four trials targeted young children. Thus, the

effect modification associated with race/ethnicity was confounded with age.

Recommendation:

There was insufficient evidence to determine the comparative effectiveness of selected

strategies of family based multicomponent behavioral interventions including goals and

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planning, comparison of outcomes, self-monitoring of behavior, self-monitoring of

outcome, contingent reward or threat, stimulus control, modeling of healthy lifestyle

behaviors by parents, motivational interviewing, or parenting skills training. Therefore,

practitioners have a fair amount of flexibility in selecting an efficacious family-based

multicomponent behavioral intervention program of sufficient intensity that addresses

physical activity, nutrition, and behavior change with strategies used to accomplish

change appropriate for particular patients and local implementation needs.

Statement of evidence rationale:

Out of 14 efficacy trials for children or adolescents with overweight or obesity, family

based multicomponent behavioral interventions with 26 or more contact hours and

clinically significant effects of ≥ -0.25 zBMI included behavioral intervention

components including goals and planning, behavioral self-monitoring, contingent

reward or threat, stimulus control, parental modeling, or parental skills training in at

least 70% of these trials. These 14 trials provide low quality evidence of no effect for

any one single intervention strategy. [Based on low quality evidence rating for

goals/planning, very low for types of goals, low for collaborative goals, low for parent

modeling and skill training, low for other components.]

Based on no comparative effectiveness trials for comparison of outcomes,

motivational interviewing, self-monitoring of behavior and outcome, contingent

reward or threat, stimulus control, and parental modeling.

Nonsignificant results from meta-regression analyses for goals/planning,

collaborative goals, parent modeling and parenting skills training.

Only 3 contradictory comparative effectiveness trials for parenting skills and also

confounded by age of children where this technique was used most often; low

quality evidence.

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Recommendation:

There was insufficient evidence to determine whether specific intervention

characteristics or strategies were associated with patient adherence (other than

attendance), engagement, or retention. Higher attendance was associated with greater

efficacy but there was insufficient evidence to determine whether patient adherence

(beyond attendance) was associated with efficacy.

Statement of evidence rationale:

No intervention strategy or characteristic was associated with patient adherence.

Patient adherence was not consistently defined or reported across studies.

Table 2: Summary of considered intervention components and association with effect size Intervention Strategy Effect size

Regression coefficient† (95% CI)

Goals and planning* -0.32 (-0.74 to 0.13) Collaborative goals 0.15 (-0.07 to 0.37) Motivational interviewing -0.03 (-0.23 to 0.29) Self-monitoring behavior -0.04 (-0.26 to 0.18) Self-monitoring of weight -0.15 (-0.44 to 0.15) Contingent reward or threat -0.15 (-0.38 to 0.07) Stimulus control 0.07 (-0.16 to 0.30) Parental modeling -0.08 (-0.30 to 0.15) Parenting skills training 0.08 (-0.16 to 0.33) Comparison of outcomes 0.20 (-0.03 to 0.43) Intervention Characteristics Contact hours -0.01 (-0.01 to -0.01) Number of sessions9 -0.01 (-0.02 to -0.01) High (≥26) contact hours -0.43 (-0.68 to -0.18) Duration -0.01 (-0.03 to 0.01) Provider Qualifications

9 While the results for contact hours and number of sessions were significant, the panel determined that the magnitude was so small as to be close to 0. Only when dichotomizing the number of contact hours into high and low did the size of the effect appear meaningful.

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Interventionist who provided the behavioral component was a behavioral specialist

-0.28 (-0.56 to 0.01)

Psychologist on team -0.17 (-0.44 to 0.10) Interventionist who provided the dietary component was a dietary specialist

0.04 (-0.25 to 0.33)

Interventionist who provided the physical activity component was a physical activity specialist

0.13 (-0.18 to 0.45)

Multidisciplinary team 0.16 (-0.09 to 0.42) Setting Primary care -0.02 (-0.28 to 0.25) Other health care -0.10 (-0.36 to 0.16) Non-health care/community 0.12 (-0.14 to 0.37) Delivery Format Offered group sessions 0.30 (-0.00 to 0.61) Offered individual (single-family) sessions -0.34 (-0.67 to -0.00) Offered individual (single-family) sessions, among trials that also provided group sessions

-0.34 (-0.73 to 0.05)

Offered sessions targeting family all together -0.01 (-0.27 to 0.24) Offered sessions targeting child only (without parent) -0.02 (-0.31 to 0.26) Offered sessions targeting parent only (without child) -0.03 (-0.31 to 0.24) Included an electronic delivery component -0.20 (-0.53 to 0.13) Included a print-based delivery component 0.07 (-0.16 to 0.30) Included a phone-based delivery component 0.11 (-0.12 to 0.34) Included supervised physical activity sessions 0.27 (-0.06 to 0.60) Included supervised physical activity sessions, among interventions offering ≥26 contact hours

0.16 (-0.59 to 0.92)

Cultural Tailoring Insufficient evidence

*Almost all trials featured this strategy so insufficient variability to yield valid meta-regression results

Potential Harms and Burdens of Treatment

Potential Harms

No medical harms for the recommended treatment were reported in studies and several

specifically indicated the following potential medical concerns did not occur: impaired height or

linear growth (Golan, Kaufman, & Shahar, 2006; Golley et al., 2007; Hughes et al., 2008;

Raynor et al., 2012; Savoye et al., 2007), development of injury or allergy (Raynor et al., 2012),

33

impaired child-health status (McCallum et al., 2007, Wake et al., 2009; Wake et al., 2013), or

increase in eating pathology (Epstein, Paluch, Saelens, Ernst, & Wilfley, 2001).

The panel recognizes that family conflict could arise during treatment. Children could

develop psychological issues related to the success or failure of the recommended intervention.

Few studies assessed psychological well-being but 11 did report on quality of life and only one

study suggested a possible negative impact from the intervention; all others reported no

difference or suggested the higher intensity intervention may result in slightly improved quality of

life.

Potential Burdens

The panel noted potential burdens, such as extra effort needed to access treatment

(recommended treatment is more often available in specialty clinics, but specialty clinics are not

in every geographical area and not always easily accessed), and lack of access to safe physical

activity and healthy foods. Another potential burden is that treatment typically requires at least

two family members, a parent and a child, to be engaged (relatively few interventions are parent

only). Not all families may have two family members, or a parent alone, ready to engage in the

recommended intervention. Another potential burden is the amount of time required (both

meeting with providers and at home); the hours can be inconvenient and be difficult and costly if

parents have to take time off from work, the child can suffer academically if needing to be

repeatedly taken out of school, and transportation can be a challenge. While there is a

relationship between an increasing number of the burdens and increased contact intensity of the

recommended intervention, the panel did not observe a difference in drop-out rate between low-

and high-intensity interventions.

The panel suggests that providers should address perceived burdens during

intervention. Further, potential burdens may be moderated by the socioeconomic status of the

family, with families of lower socioeconomic status perceiving potential burdens as larger

barriers to participating in the recommended treatment. Note however that these data were not

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systematically analyzed- they come mostly from anecdotal reports from clinicians and

community members and from public health reports regarding access to food and activity.

Implementation

The primary focus of this guideline is to provide evidence-based recommendations for

interventions used in the treatment of childhood obesity. Based on the synthesis of the

literature, this section will highlight program components and potential barriers and strategies to

be considered for successful program implementation. Five things in particular should be

considered for successful implementation:

First, it is unknown if all of the strategies of successful trials noted above are necessary

or how each affect individual outcomes. There was no direct evidence to support a specific

strategy or mode of delivery of dietary intervention or physical activity regimen over another.

Thus, until further research compares strategies directly, practitioners have a fair amount of

flexibility when choosing specific elements or mode of delivery within the areas of physical

activity, nutrition, and behavioral change when providing care or establishing new programs,

especially in order to match specific characteristics of the family or situation. The panel

recommends utilizing all the strategies employed in one of the studied, efficacious intervention

programs when offering care. The panel notes that the data either suggests no bearing on

efficacy or inconclusive evidence regarding whether to offer care in group sessions, family

sessions or individual (single family) sessions, once again providing some opportunity to tailor

delivery of care to the local setting.

Second, flexibility in treatment setting together with problem solving is needed to

address location and other practical concerns that are potential barriers to treatment. Since

there was insufficient evidence to recommend a specific program venue, offering care in the

variety of settings available in rural and urban areas, such as schools, medical settings,

community centers and faith-based settings, is important to increase accessibility. Additional

35

concerns include program cost and waitlists. During program development, other barriers to

attendance (e.g. scheduling, transportation, and childcare) should be anticipated with potential

solutions made available to the family. Technology and mHealth may provide additional

solutions to address practical concerns that limit accessibility of care. Systematically

documenting and assessing the value of such solutions may provide much needed guidance to

others overcoming implementation barriers.

The third implementation consideration relates to the age of the child. Evidence

suggests treatment may work especially well for young children, supporting the importance of

intervening as early as possible. Very few trials targeted adolescents and the trials that did

failed to meet clinical significance. Specifically, only three trials targeted adolescents exclusively

(aged 12 and up) whereas six trials targeted children aged six and younger, 17 trials targeted

children aged 6-12, and the remaining 10 trials spanned multiple age ranges. However, due to

the limited studies targeting adolescents, the increased risk for the obesity to carry over into

adulthood, and the subsequent risk of the development of weight-related comorbidities, it is

recommended that further research be conducted on this high-risk age group. It would be

particularly important to determine whether alternative treatments may be more efficacious

among adolescents. As programs are developed for each of the age groups, the child’s

developmental age as well as the participants’ culture, values and preferences should be

integrated into the interventions (i.e., see Falbe, Cadiz, Tantoco, Thompson, & Madsen, 2015;

and Hammons, Wiley, Fiese, & Teran-Garcia, 2013). Addressing these issues will support

respect for the family and participant engagement in the program.

The fourth implementation consideration pertains to the need for practitioners to develop

knowledge, skills, and awareness related to weight bias and stigma (differential and negative

treatment and attitudes experienced by people who have overweight or obesity). Health

professionals and family members have been identified as the most frequent sources of weight

stigma for individuals with obesity (Puhl & Brownell, 2006; Puhl & Latner, 2007; Puhl, et al.,

36

2013). Weight stigma has a negative effect on weight management. An increased exposure to

weight stigma is associated with higher BMI and controlled research has found increased

cortisol and caloric consumption in adult women following stigmatization (Schvey, et al., 2011;

Schvey, Puhl, & Brownell, 2014). Consequences of weight stigma reported in children include

psychosocial concerns of lower self-esteem, depression, body dissatisfaction, and a negative

impact on their interpersonal relationships (Puhl & Latner, 2007). Thus, in the panel’s expert

opinion, it is critical that providers implementing the intervention be educated about weight bias

and stigma, and develop awareness and skills to interact with children and families in a

nonjudgmental and empowering manner. Furthermore, the panel encourages providers to work

with children and parents to address stigma that may be occurring within the family (e.g. name-

calling, shaming, and criticism related to weight). Individuals may want to be familiar with the

Provider Competencies for the Prevention and Management of Obesity (Robert Wood Johnson

Foundation, 2017). Pont and colleagues (2017) published an important summary regarding

“stigma experienced by children and adolescents with obesity” and concluded with important

recommendations for pediatricians that are relevant to all providers. These include modeling

nonbiased behavior toward children with obesity, using neutral words in conversation and

clinical documentation, creating welcoming clinical environments and offering behavior change

counseling.

Fifth and finally, these are multicomponent interventions, often delivered by

multidisciplinary teams. These interventions can be delivered in specialty clinics as well as

integrated care settings, but consensus suggests that providing treatment for obesity within

integrated systems of care is preferred (Wilfley et al., 2016). Integrated care that includes both

physical and behavioral health experts has been shown to provide many benefits to patients

through improved adherence to treatment recommendations, decrease in hospitalizations and

improvements in patient outcomes (American Psychological Association, 2016). The care

delivery team for the treatment of children with overweight and obesity typically consists of a

37

primary provider tasked with medical oversight along with a behavioral health care provider

specifically trained in the management of childhood obesity. Additional team members may

include physical activity specialists and dietitians. Team members need to possess skills in

working across disciplines, communicating, and working collaboratively with other providers and

the patient and family to accomplish shared goals.

Discussion

Applicability of Results and Clinical Significance

The trials included in our review spanned a range of ages, settings, recruitment

methods, and types of professionals delivering the intervention. There was insufficient evidence

to conclude that type of setting or provider has an effect on outcome of the child’s BMI. It should

be noted that high intensity intervention studies were more likely to report that providers had

expertise in behavior change, diet and physical activity. Multiprofessional competencies for

providers of care for individuals with overweight and obesity include not only appropriate

discipline expertise (such as knowledge of diet and nutrition or knowledge of principles of

behavior change) but also knowledge and skills specific to the physiology of overweight and

obesity, interprofessional team work and other areas (Robert Wood Johnson Foundation, 2017).

There is some concern, however, about the applicability of results for certain

populations, including groups most affected by obesity. Race and ethnicity were not reported in

many trials, and there were relatively few trials that included at least 50% black or Hispanic

youth, who are disproportionately affected by obesity. Trials including a significant number of

Latino or African American participants were more likely to include interventions that were

culturally tailored, had supervised physical activity, and occurred in non-health care settings.

However, due to the poor overall quality of the data these findings were not able to be

considered in drafting recommendations.

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The panel was also not able to answer questions related to socioeconomic status due to

limited data, and very few trials specifically targeted participants of low socioeconomic status.

Regarding age, there is some evidence that family-based interventions geared toward younger

children are more likely to meet clinical significance. None of the trials targeting adolescents met

the threshold for clinical significance; thus, there is some question of applicability of the

recommendation for this population. Adolescents with obesity represent a population at high risk

for adult obesity and obesity-related comorbidities, it is critical that attention be given to finding

appropriate and effective interventions for them.

Additionally, studies with youth who have an eating disorder, were pregnant or

postpartum, or have overweight or obesity secondary to a genetic or medical condition were not

included in the review. While these youth also could potentially benefit from family-based,

multicomponent behavioral interventions, modifications may be needed with these populations

and this is an important area for further research. Children and adolescents with eating

disorders, for instance, may have problematic eating patterns or beliefs about food that will need

to be addressed along with supportive changes to diet (Cena et al., 2017) and research

suggests that family-based multicomponent behavioral interventions that focus on healthy

eating and activity behaviors either do not affect or do decrease eating disorder pathology

(Balantekin et al., 2017). Those females who are pregnant or postpartum or have a genetic or

medical condition may have specific dietary or other health care needs that must be addressed

along with the implementation of the behavioral intervention.

The panel only examined BMI/zBMI as an outcome as that was the only outcome

consistently captured across studies; therefore, while interventions may have impacted other

outcomes including health behaviors (e.g. food choices, amount of exercise), other

anthropometric variables besides BMI, and/or psychosocial variables, any of which could affect

weight status over time, it would not be captured in this document. Thus, recommendations

could shift or be refined as more data become available for other indicators of behavior change

39

or health status. However, the lifestyle focus of the intervention results in improvements in

eating habits and activity levels which in and of themselves can have important benefits,

independent of changes in BMI/zBMI. Further, the level of obesity in the children represented in

these trials tended to be quite high. Across all 36 efficacy trials, the average baseline zBMI was

2.1 (weighted by the trials’ sample sizes), which is well above the zBMI for the 95th percentile of

1.645. The panel does not know if or how its recommendations apply for children closer to the

95th percentile.

Consideration of Patient Values and Preferences

The panel supported adoption of the 26-contact hour recommendation as a necessary

minimum treatment level. For many children and families, more contact hours, including ongoing

support, will be necessary to have an impact on weight trajectory. Thus, the panel believes the

guideline recommendations are a minimum first-step towards addressing and treating childhood

obesity.

While supporting the overall guideline, the panel noted several challenges surrounding

its implementation. First, some parents may not identify their child with overweight or obesity

while health care providers might consider the child with obesity or overweight thus resulting in

different understanding of possible long-term health consequences. Several studies have shown

that parents often misperceive their child’s weight status. Misperception of weight status can be

associated with a number of factors including the child’s birth weight or sex (Manios, Kondaki,

Kourlaba, Vasilopoulou, & Grammatikaki, 2009), parental education level (De Hoog, Stronks,

van Eijsden, Gemke, & Vrijkotte, 2012 ), and even the parents’ perception of their own weight

(Lundahl, Kidwell, & Nelson, 2014).The panel supported increasing awareness of this issue,

especially among health care providers who are in a position to monitor a child’s weight

trajectory, discuss weight status with patients and parents, and recommend treatment to

minimize or eliminate associated health consequences (Lundahl et al., 2014).

40

Second, handling the logistics of a family-based, time-intensive treatment program could

be problematic for many families. Competing time issues with work and school could prevent

successful participation in an adequate treatment program. Other logistical issues, such as

childcare for young children and transportation to the treatment location, could create other

barriers. These barriers are likely to be higher for lower-income families. The panel urges

providers to consider these logistical problems when creating treatment programs. For instance,

time-sensitive scheduling, such as offering treatment during evening and weekend hours, could

alleviate some of these problems.

Third, obtaining 26 or more contact hours may be cost-prohibitive for many, if not most

families. Insurance coverage for treatment of obesity varies such that behavioral counseling by

a primary care provider for adults is typically covered but the treatment is not intensive nor

provided by specialists and coverage for children and adolescents is more variable, particularly

within the Medicaid system. Most coverage does not include participation in intensive

multicomponent treatment, weight management programs or nutritional counseling. Similar to

logistical issues, cost issues will likely have a larger negative impact on low-income families.

See Wilfley et al. (2016) for further discussion on this topic. The panel urges providers,

professional associations, and patient advocacy organizations to continue to work with

insurance companies and government policy-makers to advance coverage for obesity

prevention and treatments generally, and for children in particular.

Finally, the panel stressed the importance of treating children with overweight or

obesity—as well as their parents—in a non-judgmental, non-stigmatizing manner. As noted,

these children are already subjected to weight-based bullying and increased stigma. Adverse

childhood experiences, such as abuse or exposure to violence, can also contribute to weight

gain and should be considered. Furthermore, children may be singled out by their peers or other

family members simply because they seek treatment or participate in a weight-management

program. In addition, parents may also suffer from overweight or obesity and either be blamed

41

or perceive being blamed for their child’s weight condition. Providers need to be sensitive to

these issues and the impact they have on the child’s self-esteem and the willingness of the child

and family to participate in treatment. The panel strongly recommends that providers be

educated about the genetic, biological, psychological, social, and environmental complexities

associated with obesity. This knowledge will allow the provider to have a fuller understanding of

the condition, grasp the challenges their patients with overweight or obesity face, appreciate the

difficulties parents encounter in helping the child manage weight, which will improve their ability

to treat their patients.

How this Guideline Compares to Other Guidelines for Treatment of Children and Adolescents with Obesity

The broad conclusion reported in this guideline, that for children or adolescents with

overweight or obesity, family-based multicomponent behavioral interventions have a small

effect, based upon trials providing moderate quality evidence, is similar to the conclusions the

2008 expert committee (Spear et al., 2007), the USPSTF (2010, 2017), and several other health

organizations (Hoelscher et al., 2013; Daniels et al., 2005; Fitch et al., 2013; NICE, 2013;

August et al., 2008; American Association of Clinical Endocrinologists and American College of

Endocrinology,1998; National Health and Medical Research Council, 2013; NHLBI, 2011;

Scottish Intercollegiate Guidelines Network (SIGN), 2010; Working Group of the Guideline for

the Prevention and Treatment of Childhood and Juvenile Obesity, 2009). The findings of the

importance of intensity of contact time, with family-based multicomponent behavioral

interventions with 26 or more contact hours providing moderate to low quality evidence of a

medium effect, and those with less than 26 contact hours providing moderate quality evidence

of no effect, is similar to the findings, both in terms of the quality of the evidence and the size of

the intervention effect, of the systematic review conducted in 2010 for the USPSTF

recommendations (Whitlock et al., 2010). Furthermore, the recommendation that family-based

42

multicomponent behavioral interventions for children and adolescents with overweight or obesity

have at least 26 contact hours is similar to both the 2010 and 2017 USPSTF recommendation.

The predominant difference between the recommendations is that the USPSTF

recommendation is for children aged 6 to 18 years, while the recommendation from this

guideline includes the age range of the systematic review, 2 to 18 years, with particular note of

the effectiveness of intervention with preschool and elementary age children diagnosed with

overweight or having obesity.

Other conclusions of this effort, including insufficient or low-quality evidence on effect

moderators and components of the intervention and patient engagement factors that most

strongly influence outcomes, reflect the lack of research conducted in this area. The need for

additional research in childhood weight intervention to strengthen recommendations has been

identified previously (Spear et al., 2007; Whitlock et al., 2010). The conclusion that there was

insufficient evidence that setting, interventionist qualifications, mode of delivery, use of

multidisciplinary team including involvement of a psychologist, or cultural tailoring, had

independent effects on zBMI is new to this effort.

Limitations of Existing Treatment Research Literature: Future Research Needs

In the systematic review, several limitations were identified, suggesting areas that

require additional research to strengthen the ability to develop practice guidelines for the

treatment of childhood overweight and obesity. One limitation is the lack of guidance regarding

the amount of reduction in adiposity needed to improve other aspects of health, particularly

cardiometabolic health, in children and adolescents. In adults, a reduction of 3-5% of weight

produces clinically relevant health benefits, such as reductions in triglycerides, blood glucose,

and hemoglobin A1C, and greater amounts of weight loss produce greater benefits, particularly

in regard to blood lipids (decreases in low-density lipoprotein cholesterol and increases in high-

density lipoprotein cholesterol) (Jensen et al., 2013). Unfortunately, in children and adolescents,

43

the degree of reduction in adiposity that is required to produce clinically relevant health benefits

has not been identified (Coppock, Ridolfi, Hayes, St. Paul, & Wilfley, 2014) although reduction in

BMI is associated with improvements in metabolic outcomes (Styne et al., 2017). Some studies

do suggest that the cut-off used in this guideline, a reduction of > 0.25 zBMI, can improve

cardiovascular risk factors in children and adolescents (Ford, Hunt, Cooper, & Shield, 2010;

Kolsgaard, Joner, Brunborg, Anderssen, Tonstad, & Andersen 2012). However, more research

is needed to establish, similarly to that which has been achieved with adults, the minimal

amount of reduction in zBMI needed to achieve clinically relevant health improvements in

children and adolescents. Identifying the minimal effect needed will assist in evaluating

treatment options for children and adolescents with overweight or obesity.

Additionally, the systematic review only focused on the outcome of adiposity, as

evidenced by BMI. The multi-component interventions may have additional benefits, including

improvements in diet quality, physical activity, and psychosocial outcomes, which were not

reviewed but would be important on their own. Systematically evaluating and reporting these

outcomes in research studies is essential. Furthermore, evaluating the durability of outcomes

over longer time periods (at 2 years or 5 years), especially by subpopulations, will serve to

further refine interventions as well as focus care appropriately.

It is important to develop clinical practice guidelines that can address the noted health

disparities in childhood obesity. Although it was determined that trials that included a significant

number of African American or Latino participants were more likely to include culturally tailored

interventions, supervised physical activity, and take place in non-health care settings, these

findings could not be considered in the recommendations due to the overall poor quality of the

data. Additionally, it is worthwhile to note that in many cases, race and ethnicity were not

reported in the participant section of the published reports. To address the significant health

disparities that do exist in childhood obesity it is imperative that researchers report the race and

44

ethnicity of their participants, consider how culturally tailored interventions may increase

treatment efficacy, and describe in detail how interventions are tailored (Seo & Sa, 2010).

Please see Table 3 for a list of future research considerations.

Similarly, there was insufficient evidence to explore the role that socioeconomic status

played in treatment efficacy. Again, there were a low number of studies that reported the

socioeconomic background of families participating in treatment programs and none that

targeted participants of low socioeconomic status. Given the disproportionate prevalence of

obesity in low-income households (Ogden, Carroll, Kit & Flegal, 2012), it is incumbent upon

researchers to accurately report the socioeconomic background of participants and design

studies that target families of low socioeconomic status such that more effective means of

treatment may be developed for vulnerable families. Further, researchers designing trials

targeting these vulnerable families will need to address issues of access to food (Baker,

Schootman, Barnidge, & Kelly, 2006) and safe physical activity (Evans, 2004).

For the key questions in the review about the impact of selected strategies of family-

based behavioral management interventions in the management of age/sex zBMI and the effect

of patient adherence, engagement, and retention, it was determined that there was insufficient

evidence. Lack of detail in methodology and/or results prevented the ability to code components

of the program and determine adherence and engagement. To assist with understanding these

factors on treatment outcomes, researchers are encouraged to provide more detail in these

areas. For example, intervention strategy implementation should be described (i.e., how the

strategy was conceptualized in the intervention, when and to whom the strategy was introduced,

and length of implementation during intervention), and participant adherence to intervention

strategy implementation should be reported (i.e., percent of time participant reported using

strategy as it was designed to be implemented in intervention).

This review was also not able to report on potential harms of the interventions. As family-

based, multicomponent behavioral interventions are considered to produce minimal harm,

45

investigators rarely report on harms. However, to fully evaluate programs, potential

physiological, as well as psychosocial (either to the child or the family), harms need to be

routinely assessed and reported.

While one objective of this effort was to provide an update on research conducted on the

efficacy of family-based, multicomponent behavioral interventions for treating child and

adolescent overweight and obesity, other key questions focused on identifying factors that may

be important for understanding how to successfully implement the intervention, who may benefit

most from the intervention, what components of the intervention are most efficacious, and areas

of patient engagement needed for successful outcomes. These types of questions may be best

addressed by effectiveness trials, and in particular, phase 3 translational trials, in which areas of

intervention adoption, adaptation, and dissemination are examined (Czajkowski et al., 2016).

As the systematic review found insufficient or low-quality research to address the key questions

focused in this area, this indicates that more translational research is needed to better inform

the development of clinical practice guidelines on weight management for children and

adolescents.

To assist with translation, the field of childhood obesity treatment could benefit from

using advances in behavioral research design, and the emerging literature on adaptive

interventions is particularly promising. Adaptive interventions anticipate response heterogeneity

and deploy intervention content depending on specific individual needs (Lei, Nahum-Shani,

Lynch, Oslin, & Murphy, 2012). For example, adaptive interventions can change or enhance

treatment dose for non-responders, re-introduce treatment for those who experience relapse,

decrease or alter dose for those who are early responders, and/or differentially adapt dose by

treatment target (e.g., parent, childcare provider, teacher). Sequential, multiple assignment,

randomized trials (SMARTs) (Lei et al., 2012) allow one to simultaneously test multiple adaptive

interventions, along with decision rules for adapting treatment. With SMARTs, researchers can

easily evaluate multiple intervention design options (e.g., dose, treatment type, delivery

46

schedule, triggering events). SMARTs may have particular benefit to setting-specific childhood

obesity treatments (i.e. school, childcare, primary care-based), in which population level

treatments are necessary. Given ever-present resource constraints, SMARTs may also benefit

efforts to identify how to best distribute treatment contact among patients and their families.

Furthermore, most childhood obesity treatments are essentially “packages” of varied

behavioral intervention components. These components are often targeted at multiple levels

(e.g., child, parent, family, household, school) and a range of theoretical mediators. A key

barrier to improving treatment efficacy is our inability to break up these black box interventions

to characterize the effect size of their discrete components. That is, traditional "gold-standard"

RCT designs cannot reveal which intervention strategies contribute most to weight change,

which might have limited influence, or which might even have detrimental effects. This limits

one’s ability to refine, enhance, or replace discrete intervention strategies. The challenge is

magnified, given the derivative nature of research-tested treatments; a strategy with suboptimal

efficacy might proliferate through multiple intervention trials, cannibalizing degrees of freedom

that might be devoted to testing novel strategies. Related, this challenge limits one’s ability to

create lean, cost-efficient interventions that can be scaled and disseminated. Use of novel

design frameworks, such as the Multiphase Optimization Strategy (MOST), can assist in

building optimized treatment packages that only contain strategies that meaningfully affect

weight change outcomes (Noser, Cushing, McGrady, Amaro & Huffhines, 2017). MOST

involves using theory to identify testable intervention strategies, which are then subjected to an

experimental trial (usually a factorial or fractional-factorial trial). Strategies meeting a pre-

defined effect size are assembled into a treatment package, which can then be tested in a

standard RCT. A key challenge facing investigations like the panel’s is the need to discern the

efficacy of treatment characteristics by examining largely non-comparable multicomponent

interventions. Rather than relying solely on these post-hoc determinations of treatment

component efficacy, MOST allows for the experimental determination of a component's efficacy

47

prior to its implementation in a multicomponent package. In this way, one might more rapidly

and systematically identify ways of enhancing treatment outcomes beyond solely increasing

treatment dose.

Finally, while the panel did not review data on the financial cost of treatment nor the

potential financial savings of successful treatment, such data would be helpful in determining

how best to allocate limited healthcare resources. Translating this data into useful, actionable

figures will be helpful to those implementing lifestyle intervention programs and those working to

convince policy makers and payers of the need for such programs.

Table 3: Items to Consider for Inclusion in Future Research Studies on Treatment

Interventions Involving Children

Race and ethnicity

Socioeconomic status

Possible harms and other adverse events associated with treatment

Methodological details of components of the intervention program including implementation

process, adherence and engagement

Outcome measures to include BMI/zBMI scores as well as standardized measures of self-

efficacy, psychosocial outcomes, metabolic functioning and other outcomes when used

Other novel designs (i.e., SMARTs)

Conclusion

This guideline for the treatment of overweight and obesity in children and adolescents

incorporates standards for trustworthy clinical practice guideline development from the former

Institute of Medicine of the National Academy of Sciences (IOM, 2011a). Thus, this guideline

follows standards required for inclusion in the National Guideline Clearinghouse. These

standards include an emphasis on using a high quality systematic review, identification and

48

management of conflicts of interest, transparency, and multidisciplinary panels. The

recommendations of this guideline are based on a rigorous systematic review that followed IOM

(2011b) standards for systematic reviews. This guideline is unique in that it included patient

values and preferences as well as information available, though limited, on harms and burdens

of treatment.

The findings of this guideline are consistent with those of other published clinical practice

guidelines for overweight and obesity and recommend family-based multicomponent behavioral

interventions with at least 26 contact hours for children and adolescents with overweight or

obesity. The guideline also recommends using these interventions, particularly with young

children diagnosed with overweight or obesity. A clinical practice guideline is a general guide to

best practices and serves as an aid in decision-making but does not define a standard of care

nor supplant clinician judgment.

Panel members recognize that while these recommendations were made based on

scientifically rigorous methods, future research is needed to address gaps in the current

scientific literature. Several of these limitations include lack of information on the adiposity

reduction amount needed to enhance other aspects of health in children and adolescents, lack

of reporting of race and ethnicity as well as socioeconomic status of study participants, and no

additional outcome measures beyond BMI/zBMI. Furthermore, information is needed on

potential harms of interventions, methodological details of the intervention program (i.e.,

implementation process, adherence, and engagement, other novel designs) and comparative

effectiveness of different change strategies.

49

Conflicts of Interest Prior to final appointment to the panel, candidates completed a conflict of interest (COI)

form that was then reviewed by the Advisory Steering Committee and APA staff to ensure there

were no identified conflicts that would prohibit participation, with the understanding that some

“adversarial conflict” representing different points of views was to be expected and encouraged

in this process. While intellectual affiliations were expected, no panel members had been

singularly identified with particular approaches to intervention or had significant known financial

conflicts. Once the panel was formed, all panel members completed an educational module on

COI that underscored the importance of identifying and managing any potential conflicts, both

financial and intellectual. The APA COI policy and disclosure form are included in the appendix.

All panel members and staff affiliated with development of the Obesity CPG updated

their COI form on an annual basis and were asked to provide more timely updates if changes in

their disclosures were perceived to be relevant to the development of the guideline. All were

asked to disclose all potential COI with the understanding that these would be reviewed and

evaluated, and a decision would be made regarding how to manage identified conflicts.

Conflicts of interest included not only possibilities for financial or professional gain but also

strong intellectual viewpoints that might then limit someone from objectively reviewing the

evidence. Emphasis was placed on disclosing all potential conflicts and allowing the staff and

chair (or other appropriate entity in the case of the chair) to review the disclosures and

determine whether or not such information could reasonably be construed as to be a source of

possible influence on the guideline development process. Furthermore, upon first joining the

initiative and at the initial face to face meeting, panel members were asked to verbalize their

conflicts, so all present would be familiar with the diversity of perspectives and range of possible

influences. This practice continued at subsequent face-to-face meetings.

All authors were required to disclose their intellectual interests, financial and

professional interests, interests related to APA, and other relevant interests. They were also

50

required to disclose interests of family members, defined as “a spouse, domestic partner,

parent, child, or other relative with whom [they] have a comparably close tie.” Authors

disclosed the following potential COI: scientific/educational/professional communications,

communications to a general audience, roles at APA or other organizations, relevant

honoraria, endorsements, research funding or royalties, payment for services or training, and

serving as expert witnesses. None of them reported conflicts of interest that precluded a

nominated candidate from serving on the GDP. The Advisory Steering Committee was aware

that excluding all GDP candidates with any potential intellectual COIs risks excluding the level

and type of expertise needed to fully evaluate treatment benefits and risks. The most

knowledgeable individuals can be conflicted because of expertise in their areas of interest, and

they may possess both financial and intellectual COIs from participating in research and

serving as consultants to industry. However, these experts may possess unique insight into

health care needs useful to development of this guideline.

There is growing recognition that financial relations to the pharmaceutical industry threaten

the integrity of research and of CPGs. However, the issue is still contentious, and exclusion of all

potential GDP members with such conflicts may itself be seen as biased against

pharmacological treatments or particular medical specialties. Similarly, experts with respect to

psychotherapy tend to have intellectual passions for specific types of psychosocial interventions

that also constitute potential conflicts. Yet, such individuals may be difficult to replace because of

their unique insights, as well as their status in the eyes of key stakeholders (IOM, 2011b).

Hence, rather than exclude topic experts and risk minimizing expertise, APA follows the principle

of adversarial collaboration in which competing interests are balanced on panels and

committees, rather than avoided. This approach is also used by other leading developer of

CPGs, such as the ACCF/AHA task force (ACCF and AHA, 2008; IOM, 2011b).

Conflict of interest forms for all authors are available by request for public review.

51

Developer

American Psychological Association (APA)- Obesity Clinical Practice Guideline Development

Panel (GDP). The Obesity GDP is a multidisciplinary Panel of experts.

Author Disclosures The Clinical Practice Guideline Development Panel reported the following disclosures during the

development and approval of this guideline:

Maria M. Llabre, PhD (Chair), is a professor of psychology, associate chair for graduate

studies and the director of biobehavioral statistics at the Behavioral Medicine Research Center

at the University of Miami. She reports no conflicts of interest with her work on this guideline.

Jamy D. Ard, MD (Vice-Chair), is an associate professor in the department of

epidemiology and prevention and the department of medicine at Wake Forest University Baptist

Medical Center. He is also the co-director of the Wake Forest Baptist Health Weight

Management Center. He regularly leads professional workshops and publishes on topics related

to obesity and obesity treatment. He receives payment directly for providing or training other

individuals to provide health services related to obesity, as well as honoraria for presentations,

discussions, and royalties. He has received funding for research or research training on

scientific or clinical issues related to obesity. He reports no conflicts of interest with his work on

this guideline.

Gary Bennett, PhD, is professor of psychology, global health, and medicine at Duke

University. He directs the Duke Obesity Prevention Program and the Duke Global Digital Health

Science. He regularly leads professional workshops and publishes on topics related to obesity.

He receives honoraria for presentations and discussions, and has received funding for research

or research training on scientific or clinical issues related to obesity. He holds equity stake in

Scale Down, a company that markets a digital health weight loss product, as well as in Coeus

52

Health, a company that develops software that allows developers to more easily create

evidence-based health applications including for obesity treatment. He reports no conflicts of

interest with his work on this guideline.

Phillip J. Brantley, PhD, is a John S. Mcllhenny Professor and Head of Behavioral

Medicine at the Pennington Biomedical Research Center at Louisiana State University in Baton

Rouge. He also serves on the Executive Council of the Obesity Society. He reports no conflicts

of interest with his work on this guideline.

Barbara Fiese, PhD, is a professor of human development and family studies at the

University of Illinois at Urbana-Champaign and director of the Family Resiliency Center. She

regularly leads professional workshops and publishes on topics related to obesity. She receives

honoraria for presentations, discussions, and royalties. She has received funding for research or

research training on scientific or clinical issues related to obesity. She reports no conflicts of

interest with her work on this guideline.

Jane Gray, PhD, serves as the director of behavioral health for the Texas Center for the

Prevention and Treatment of Childhood Obesity, an interdisciplinary pediatric weight

management program in central Texas. She regularly leads professional workshops and

publishes on topics related to obesity. She receives payment directly for providing or training

other individuals to provide health services related to obesity. Currently, she is participating in

the “Expert Exchange,” which is a collaboration between the Children’s Hospital Association and

the American Academy of Pediatrics, focusing on targeting pediatric obesity in primary care,

and addressing severe obesity. She reports no conflicts of interest with her work on this

guideline.

Patty Nece, JD, is the counsel for regulations and legislation in the U.S. Department of

Labor’s Office of the Solicitor’s Division of Black Lung and Longshore Legal Services. She

53

regularly leads professional workshops on topics related to obesity. She receives honoraria for

presentations and discussions. She reports no conflicts of interest with her work on this

guideline.

Michele Polfuss, PhD, RN, CPNP-AC/PC, is a pediatric nurse practitioner and assistant

professor. Currently, she works at the University of Wisconsin – Milwaukee College of Nursing

and holds the position of Joint Research Chair in the Nursing of Children between the University

of Wisconsin-Milwaukee and Children’s Hospital of Wisconsin. She has experience leading

professional workshops and publishes on topics related to obesity. She receives honoraria for

presentations and discussions on obesity. She is an active researcher who has received funding

for research or research training on scientific or clinical issues related to childhood obesity and

obesity in developmental disabilities. In 2015, she joined the “Healthy Weight Research

Network,” researching obesity in individuals with developmental disabilities and autism. She

reports no conflicts of interest with her work on this guideline.

Hollie Raynor, PhD, RD, LDN, is a registered dietician and clinical psychologist. She is

an associate professor in the department of nutrition at the University of Tennessee. She

regularly leads professional workshops and publishes on topics related to obesity. She receives

honoraria for presentation and discussions on obesity. She has received research funding from

Weight Watchers International for research in adult weight management. She reports no

conflicts of interest with her work on this guideline.

Delia Smith West, PhD, is a South Carolina SMART State Endowed professor of

exercise science, and the director of the Technology Center to Promote Healthy Lifestyles at the

University of South Carolina. She regularly leads professional workshops and publishes on

topics related to obesity. She receives payment directly for providing or training other individuals

to provide health services related to obesity as well as honoraria for presentations and

54

discussions. She has received research funding from the National Institute for Health (NIH).

She reports no conflicts of interest with her work on this guideline.

Denise Wilfley, PhD, is a Scott Rudolph University professor of psychiatry, medicine,

pediatrics, and psychology at Washington University in St. Louis. She regularly leads

professional workshops and publishes on topics related to obesity. She receives payment

directly for providing or training other individuals to provide health services related to obesity as

well as honoraria for presentations and discussions. Currently, she is the principal investigator

on an NIH/NHLBI T32 training grant called, “Nutrition-Behavioral Cardiovascular Disease

Prevention.” She is on the Advisory Board for several obesity-related centers, and has held or

currently serves in leadership roles for several scientific and advocacy organizations addressing

the topic of obesity. She reports no conflicts of interest with her work on this guideline.

Conflict of interest forms for all authors are available by request for public review.

 

55

Funding Source/Sponsor

This guideline was developed with financial support from the American Psychological

Association. The Obesity GDP functioned as an independent Panel of the association. Final

recommendations were reviewed by the APA Council of Representatives for approval (yes or

no) as APA policy. However, the Council had no influence on the content of the

recommendations.

 

56

Acknowledgments

The panel is grateful to APA Executive Director of Practice, Dr. Katherine Nordal for her endless

support and championing of this initiative as well as APA’s Board of Professional Affairs, Board

of Scientific Affairs, Council of Representatives, and Board of Directors. The panel thanks the

members of the Advisory Steering Committee for the Development of Clinical Practice

Guidelines who provided guidance and feedback during the course of creating this guideline.

The panel appreciates the work of APA staff Dr. C. Vaile Wright and Ms. Shannon Beattie

supporting the work of this panel. The panel is grateful to Kaiser Permanente Research

Affiliates EPC scientists for their systematic review work and methodological guidance. The

panel extends its thanks to two initial panel members, Dr. Leonard Epstein and Ms. Caroline

Jhingory.

  

57

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Appendices

Appendix A Definitions of Key Terms

Advisory Steering Committee (ASC). The Advisory Steering Committee is a group of distinguished

psychologists appointed by the APA Board of Directors (BOD) to oversee APA’s CPG development process. The ASC selects which nominated topics will be considered for guidelines and assembles the Panels who write the guidelines, but they are not directly involved in conducting SRs, nor in writing CPGs. In addition, while the ASC reports to the BOD and was initially constituted by a subcommittee representing the Board of Professional Affairs (BPA), the Board of Scientific Affairs (BSA), and the Committee for the Advancement of Professional Practice (CAPP), the ASC operates autonomously from APA governance to prevent real or perceived COIs.

Agency for Healthcare Research and Quality (AHRQ). One of 11 agencies within the Department of Health and Human Services, AHRQ supports research that helps people make more informed decisions and improves the quality of health care services. AHRQ’s mission is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans, with the following focus areas: comparing the effectiveness of treatments; quality improvement and patient safety; health information technology; prevention and care management; and health care value. AHRQ develops systematic reviews on topics of greatest public health impact. Topic nomination is an open process through AHRQ’s Effective Healthcare Program; APA plans to use this mechanism to support SRs for CPG development.

Applicability. Applicability is analogous to external validity or generalizability (IOM, 2011a). Consideration of such is consistent with the aim of helping consumers, clinicians, purchasers, and policy makers make informed that decisions that will improve health care at both the individual and population levels.

Benefit. A positive or valued outcome of an action or event. (IOM, 2011a).

Bias. A systematic deviation or process that favors one outcome over others (Gluud, 2006). Bias may lead to under- or over-estimation of treatment effects. It is impractical and most likely impossible to quantify every potential source of bias that may influence an individual study (Chavalarias & Ioannidis, 2010); however, a number of specific methodological flaws or limitations in research design, implementation, analysis, and evaluation often produce biased outcomes.

Comparative effectiveness research (CER). The generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to help consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels. Also referred to as clinical effectiveness research (IOM. 2011a).

Confidence interval (CI). A confidence interval is a range around an estimate that conveys how precise the estimate is; for example, an estimate of the risk of an event occurring or an estimate such as a risk ratio that compares the risk with and without an intervention. The confidence interval is a guide to how sure we can be about the quantity we are interested in. The narrower the range between the two numbers, the more confident we can be about what the true value is; the wider the range, the less sure we can be. The width of the confidence interval reflects the extent to which chance may be responsible for the observed estimate (with a wider interval reflecting more

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chance). 95% Confidence Interval (CI) means that we can be 95 percent confident that the true size of effect is between the lower and upper confidence limit. Conversely, there is a 5 percent chance that the true effect is outside of this range (DECIDE, 2012).

Effectiveness. The impact of an intervention compared to active treatment.

Efficacy. The impact of an intervention compared to an inactive control.

Estimate of effect. The observed relationship between an intervention and an outcome expressed as, for example, a number needed to treat to benefit, odds ratio, risk difference, risk ratio, standardized mean difference, or weighted mean difference.

Evidence. Information on which a decision or guidance is based. Evidence is obtained from a range of sources, including randomized controlled trials, observational studies, and expert opinion of clinical professionals or patients (IOM, 2011b).

Evidence Tables. Abstracts of data included in the systematic review and include, as available for each body of evidence, the number of studies, effect sizes, confidence intervals (when available) and quality ratings

GRADE (GRADE collaboration and Framework). The Grading of Recommendations Assessment, Development and Evaluation (GRADE) Consortium Working Group, which began in the year 2000, is an international collaboration of scholars with an interest in addressing the shortcomings of present grading systems for CPGs in health care. The working group has developed a sensible and transparent framework for grading strength of evidence and strength of recommendations, typically referred to as “GRADE” (or the GRADE system). Many international organizations provided input into the development of the approach and have started using it (for further information, see http://www.gradeworkinggroup.org/).

Grid. A document developed and used by panel members to summarize and evaluate the evidence generated in the systematic review, along with any supplemental information.

Guideline Development Panel (GDP). A multidisciplinary Guideline Development Panel is assembled for the purpose of developing a specific CPG. GDPs are tasked with generating treatment recommendations from systematic reviews, and drafting the content of the CPGs. These activities take place independently from APA governance/staff, the ASC, and Systematic Review Teams, who play no part in developing the CPG recommendations. There is some interaction between the SRT and GDP to ensure that the systematic review will meet the needs of the CPG developers; yet, the nature of the interaction is transparent and circumscribed to maintain the objectivity and validity of both the systematic review and the CPG.

Harm. A hurtful or adverse outcome of an action or event, or with regard to CPGs, a treatment or health care decision/recommendation, whether temporary or permanent (IOM, 2011b).

Institute of Medicine (IOM). A private, nonprofit institution that provides objective, timely, authoritative information and advice concerning health and science policy to the government, the corporate sector, the professions, and the public under a congressional charter.

Meta-analysis. The use of quantitative statistical methods in a systematic review to integrate the results of included studies.

Outcome. A change resulting from an intervention. In evaluations, a potential consequence of an intervention that is measured after the intervention has been implemented, that is used to assess

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the potential beneficial and harmful effects of the intervention. Critical outcomes are the outcomes of greatest importance for answering key questions in systematic reviews (Boyd et al., 2012).

Patient-centeredness. Respect for and responsiveness to individual patient preferences, needs, and values; helps ensure that patient values and circumstances guide clinical decisions (IOM. 2011a).

PICOTS (questions). Systematic reviews seek to answer clearly formulated key questions that will simplify decision-making about real world practices, and thereby inform CPG recommendations. These key questions are developed using the PICOTS framework, an acronym denoting components that should be specified in each key question: Patient populations (P), Interventions (I), Comparison conditions (C), Outcomes (O), Timing or timeframe (T), and Settings (S). For this reason, the key questions in systematic reviews are frequently referred to as PICOTS (or PICOTS questions). Timing and Settings are newer additions to the framework; hence, key questions may also be called PICOS (or PICO questions) by some investigators.

Publication bias. A bias caused by only a subset of all the relevant data being available. The publication of research can depend on the nature and direction of the study results. Studies in which an intervention is not found to be effective are sometimes not published. Because of this, systematic reviews that fail to include unpublished studies may overestimate the true effect of an intervention. In addition, a published report might present a biased set of results (e.g. only outcomes or sub-groups where a statistically significant difference was found).

Quality of evidence. The extent to which one can be confident that the estimates of an intervention's effectiveness are adequate to support a particular decision or recommendation (IOM, 2011b; Schünneman et al., 2011). AHRQ uses “strength of evidence” (SOE) to refer to the same basic concept.

Randomized controlled trial (RCT). An experiment in which two or more interventions, often including a control intervention or no intervention, are compared by randomly allocating participants to the interventions. The term ‘trial’ is sometimes used to refer to randomized controlled trials (RCTs); however, the term may also be used to refer to quasi-randomized trials (which do not randomly assign participants to groups).

Relative Effects. A quantitative measure for evaluating harms and benefits of treatment, expressed as the ratio of two indicators of the frequency of the outcome. A risk ratio (RR) is the ratio between the risk (incidence) of the outcome event in the intervention group and the risk in the control group. For example, if the risk of the outcome event in the intervention group is 5% (5 per 100) and the risk in the control group is 20% (10 per 100), the RR is .05 / .20 = .25. If the RR is less than 1, the risk of the outcome event in the intervention group is less than the control group. If the RR is equal to 1, the risk in the two groups is equal. If the RR is greater than 1, the intervention increases the risk of the outcome compared to the control group. An odds ratio (OR) is also a measure of relative effects, in this case, the odds (not risk) in the intervention group compared to the odds (not risk) in the control group. An odds is a mathematical formula for the probability of an event happening divided by the probability of that event not happening or, mathematically: odds = p / (1-p). Thus, if the risk in the intervention group is 5% (i.e., .05), then the odds in the intervention group is .05 / .95 = .05 (with rounding). If the risk in the control group is .20, then the odds in the control group is .20 / .80 = .25. The odds ratio is then .05 / .25 = .20. Odds ratios can be interpreted similarly to risk ratios. However, when the risk of the outcome event is high, the odds ratio will be different from the risk ratio.

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Risk of bias. The extent to which flaws in the design and execution of a collection of studies could bias the estimate of effect for each outcome under study (IOM, 2011b).

Strength of Evidence. The extent to which one can be confident that the estimates of an intervention's effectiveness are adequate to support a particular decision or recommendation (IOM, 2011b; Schünneman et al., 2011). GRADE uses “quality of evidence” to refer to the same basic concept.

Strength of Recommendation. The strength of a recommendation reflects the extent to which one can be confident that the desirable outcomes of a treatment alternative outweigh the undesirable outcomes, across the range of patients to whom the recommendations apply (IOM, 2011b; Schünneman et al., 2011).

Study Quality. For an individual study, study quality refers to all aspects of a study’s design and execution and the extent to which bias is avoided or minimized. A related concept is internal validity; that is, the degree to which the results of a study are likely to be true and free of bias (IOM, 2011b).

Systematic Review (SR). A rigorous approach to synthesizing data from research studies on the benefits, harms and effectiveness of alternative treatment options that pertain to a particular clinical population (IOM, 2011b). Systematic reviews use pre-specified criteria for screening, selecting, appraising, grading, and synthesizing outcomes, from a body of research studies, to answer specific clinical questions in areas of uncertainty. SRs seek to minimize bias by using explicit, standardized procedures (Green et al., 2008). The use of standardized criteria enhances the reliability of the findings and confidence in the conclusions about the relative advantages of alternate treatment approaches (IOM, 2011a).

Transparency. Methods are explicitly defined, consistently applied, and available for public review so that observers can readily link judgments, decisions, or actions to the data on which they are based. Allows users to assess the strengths and weaknesses of the systematic review or CPG (IOM, 2011a).

Treatment Recommendation. In the context of CPGs, treatment recommendations are statements that propose a course of action with respect to a specific health care service, test, therapy, or procedure. Well-constructed recommendations specify what should be offered or provided to patients, as well as under what specific conditions the recommendation applies (Rosenfeld & Shiffman, 2009; Shiffman, 2009). In addition, the IOM (2011b) specifies that CPG recommendations should include alternative treatment options.

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Appendix B

APA Declarations/COI Form

American Psychological Association

Clinical Practice Guideline Initiative

CONFLICT OF INTEREST POLICY

and

DECLARATION OF INTERESTS

2015

Covered Individual (please type your name and current date) Name: Date: Please indicate with an ‘X’ your role(s) in the initiative: ___ Advisory Steering Committee (ASC) Member ___ Guideline Development Panel (GDP) Member If GDP Member, please name the topic of the Panel: ___ Consultant ___ APA Staff Member Instructions: Please read the Conflict of Interest Policy, fill out the Declaration of Interests, and sign the statement at the end.

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Conflict of Interest Policy It is the aim of the American Psychological Association (“APA”) to transact all of its business, including the APA clinical practice guideline initiative, lawfully and impartially. In some situations, the relationship of a Covered Individual (as defined below) with a third party, financial or otherwise, could reasonably be construed to create a conflict between the interests of APA and the interests of the Covered Individual.

Covered Individuals are required to disclose to APA any actual, potential, or perceived conflict of interest (COI) with APA or with their role in the clinical practice guideline initiative, including conflicts from the past 12 months and expected conflicts in the upcoming 12 months. A COI may be of a financial, intellectual, or other nature, as defined below. APA requires Covered Individuals to disclose COIs prior to official appointment to a committee/Panel or as a consultant, as well as at the time points noted below. The existence of COIs will not necessarily preclude participation in the guideline initiative, although it may require limiting a Covered Individual’s role. APA staff involved in the initiative may also be asked by their supervisors to disclose COIs, following the same policy as for Covered Individuals. This policy is designed to promote transparency, to protect the integrity of the guideline initiative, and to provide a mechanism to help protect Covered Individuals and APA from legal concerns associated with conflicts of interest. Covered Individuals: This policy applies to members of the Advisory Steering Committee and the Guideline Development Panels of the APA clinical practice guideline initiative and to consultants who are formally engaged by APA for work on the initiative. Term: Covered Individuals shall be bound by this conflict of interest policy during the official term of their position on the committee/Panel or as a consultant. Definition of COI: A 2011 report from the Institute of Medicine includes the following definition of COI: “a divergence between an individual’s private interests and his or her professional obligations such that an independent observer might reasonably question whether the individual’s professional actions or decisions are motivated by personal gain, such as financial, academic advancement, clinical revenue streams, or community standing.” (See Institute of Medicine, 2011, p. 78; the definition is drawn from Schünemann et al., 2009, p. 565.) The Institute of Medicine report also discusses intellectual COIs relevant to clinical practice guidelines, which it defines as “academic activities that create the potential for an attachment to a specific point of view that could unduly affect an individual’s judgment about a specific recommendation” (Institute of Medicine, 2011, p. 78; this definition is drawn from Guyatt et al., 2010, p. 739.) COIs can arise in various situations and may involve the individual or a member of the individual’s family (spouse, domestic partner, parent, child, or other close relative). Examples of potential COIs include, but are not limited to, the following: Receiving payment for directly providing, or training other professionals to provide, health services related to the topic(s) of the guideline(s) being developed. Receiving honoraria for presentations or discussions of scientific or clinical issues related to the topic(s) of the guideline(s) being developed.

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Receiving royalties for books or other materials that address scientific or clinical issues related to the topic(s) of the guideline(s) being developed. Receiving funding, in the form of grants or contracts, for research on scientific or clinical issues related to the topic(s) of the guideline(s) being developed. Serving in a governance or other volunteer position in an organization that provides health services, promotes research related to health services, or develops or advocates for health service policies, related to the topic(s) of the guideline(s) being developed. Having strongly held opinions or other intellectual biases that might compromise objectivity in addressing the topic(s) of the guideline(s) being developed. Having a significant ownership interest in or significant capacity to influence decisions of a firm or organization that is an APA competitor, customer, or supplier, or a firm that conducts research or provides health services related to the topic(s) of the guideline(s) being developed. Being employed by or performing other work (including consulting) for a competitor, customer, or supplier of APA, regardless of the nature of that work. Conduct of APA business of any kind, or arranging for such business, with a firm that one owns or controls. Acceptance of any money, property, or anything of value from a person or firm doing or seeking to do business with APA. Receipt of direct or indirect economic benefit as a consequence of acquisition, lease, or sale by APA of any property, facilities, materials, or services. COI Reporting: Covered Individuals must complete a Declaration of Interests form (appended below) disclosing any actual, potential, or perceived COIs prior to appointment to a committee/Panel or as a consultant, and thereafter on an annual basis. If, during the year, a change occurs in a Covered Individual’s COIs or in his/her family members’ COIs, the Covered Individual must report that information immediately to APA staff who work on the clinical practice guideline initiative, who will share it with the relevant committee/Panel Chair or Vice Chair. Covered Individuals are expected to provide any updates regarding their COIs orally at the beginning of all official committee/Panel meetings. In addition, Covered Individuals should disclose any professional papers or presentations on which they are listed as authors, prior to publication or delivery, that pertain to the topic(s) of the guideline(s) with which they are involved. This disclosure should be made to APA staff involved in the initiative. If a Covered Individual is unsure whether particular information should be reported, or if the information is sensitive or confidential, the Individual may first consult with APA staff involved in the initiative about whether and how to report it. With the individual’s permission, the staff may then seek further guidance from the Chair or Vice Chair of the relevant committee/Panel. Disclosure of any actual, potential, or perceived COI is the responsibility of everyone participating in the clinical practice guideline initiative. In general, if any Covered Individual or APA staff member is aware of circumstances that may constitute a COI involving another participant in the initiative, then he/she should first discuss it with that participant. If such a discussion is not appropriate or if the discussion does not produce a satisfactory result, then he/she should discuss it with APA staff and/or the relevant committee/Panel Chair or Vice Chair. COI Review and Management: Each Covered Individual’s completed Declaration of Interests form will be reviewed by APA staff and by the Chair and/or Vice Chair of the relevant committee/Panel (or only by APA staff for consultants). The individual’s résumé or curriculum vitae, as well as publicly available materials about the individual, may also be examined in the

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course of the review. The primary purpose of the review is to determine whether the individual has any actual, potential, or perceived COIs that would preclude the individual from participation in the clinical practice guideline development initiative or require resignation from any role that he/she already has in the initiative. Having one or more COIs does not necessarily mean that a Covered Individual cannot be involved in the initiative. If the reviewers determine that an individual’s COIs do not preclude participation, then the reviewers will identify what actions, if any, may be needed to resolve or manage the impact of the COIs on the integrity (both actual and perceived) of the initiative. Examples of such actions may include limitations on the individual’s participation in discussions, deliberations, or voting on specific matters and not being counted in determining a quorum for all or portions of a particular committee/Panel meeting. Such actions would not prevent the individual from briefly stating his/her position or answering questions on relevant matters. Possible actions for managing the impact of COIs will be discussed with the Covered Individual, but final decisions on which actions are taken are made by APA staff in consultation with the relevant committee/Panel Chair and/or Vice Chair. In some cases, the APA General Counsel may participate in making such decisions. Also, in some cases in which the Covered Individual is a member of a Guideline Development Panel or a consultant, the Chair and/or Vice Chair of the Advisory Steering Committee may participate in making such decisions. If any new COIs are reported or discovered during the period after a Declaration of Interests form has been submitted, APA staff and the relevant committee/Panel Chair and/or Vice Chair will determine whether any further actions are required for managing their impact on the initiative. For Covered Individuals who are members of a committee/Panel, information about all actual, potential, and perceived COIs are shared with all other members of the committee/Panel. Information about all actions taken to resolve or manage the impact of COIs are also shared with all members of the committee/Panel.

Record of COIs: APA retains a copy of all completed Declaration of Interests forms and related documents. Summary information about Covered Individuals’ COIs and of actions taken to manage their impact will be available for public view. (No information will be publicly released about people who are nominated or considered for positions on a committee/Panel or as consultants but not selected.) Additional information about COIs and actions taken may appear in meeting minutes and summaries, which will also be available for public view. It is also possible that additional information will be made public in response to inquiries. References Guyatt, G., Akl, E. A., Hirsh, J., Kearon, C., Crowther, M., Gutterman, D., Lewis, S. Z., Nathanson, I., Jaeschke, R., & Schünemann, H. (2010). The vexing problem of guidelines and conflict of interest: A potential solution. Annals of Internal Medicine, 152(11), 738–741. Institute of Medicine (2011). Clinical practice guidelines we can trust. Washington, DC: National Academies Press. Schünemann, H. J., Osborne, M., Moss, J., Manthous, C., Wagner, G., Sicilian, L., Ohar, J., McDermott, S., Lucas, L., & R. Jaeschke. (2009). An official American Thoracic Society policy

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statement: Managing conflict of interest in professional societies. American Journal of Respiratory Critical Care Medicine, 180(6), 564–580. Declaration of Interests The purpose of this Declaration is to identify your actual, potential, and perceived conflicts of interest with APA and with your role in the APA clinical practice guideline initiative. Having conflicts of interest does not necessarily preclude participation in the initiative. Decisions about how conflicts should be managed will be made by APA staff in consultation with the Chair or Vice Chair of any committee or Panel of which you are a member. Please answer the following questions by marking either ‘Yes’ or ‘No’ and then explaining any ‘Yes’ answers in the space immediately following or by attaching supplementary materials. When responding, please think about the full range of research, teaching, practice, writing, service work, and professional relationships in which you and your family members are involved. (You may consult with APA staff in advance if you have any questions or concerns about what information to provide on this form.) The questions are organized into four sections:

Intellectual Interests

Financial and Professional Interests

Interests Related to APA

Other Relevant Interests

For the purposes of this Declaration, a family member is a spouse, domestic partner, parent, child, or other relative with whom you have a comparably close tie. Please attach a CV, résumé, or other materials if these are needed to provide complete answers. (Questions begin on next page.)

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INTELLECTUAL INTERESTS (The questions in this section concern only you, not family members.) 1. Scientific/educational/professional communications Over the past 12 months, have you had any scientific, educational, or professional publications (including in-press) or made any scientific, educational, or professional presentations related to the topic(s) of the guideline(s) that you will be involved in developing or overseeing? Has your name been included on a relevant speakers’ bureau list? Please include both paid and non-paid work. ___ Yes ___ No Do you expect that, over the next 12 months, you will have any such publications or presentations or that your name will be included on a speakers’ bureau list? ___ Yes ___ No If ‘Yes’ to any of these questions, please provide a list of the relevant publications, presentations, courses, and speakers’ bureaus. You may attach a copy of your CV or résumé but please make sure to add any items that do not yet appear on those documents. [Insert material here] --------------------------------------

2. Communications with general audiences

Over the past 12 months, have you made presentations to a general (non-academic, non-scientific) audience that address research, clinical, or policy issues related to the topic(s) of the guideline(s) that you will be involved in developing or overseeing? Have you been involved in organizing any events that include such presentations?

___ Yes ___ No

Over the past 12 months, have you published articles or books for a general audience or produced materials for television, radio, or the Internet (e.g., blogs, online petitions, Facebook, LinkedIn, TED Talks, Twitter, YouTube) that address these issues? Please include both paid and non-paid work. You need not include formal research publications for academic or scientific audiences.

___ Yes ___ No

Do you expect that, over the next 12 months, you will be involved in any such activities? ___ Yes ___ No

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If ‘Yes’ to any of these questions, please provide a list of the presentations and published/posted materials. You may attach a copy of your CV or résumé but please make sure to add any items that do not yet appear on those documents. [Insert material here] --------------------------------------

3. Expert witness

Over the past 12 months, have you served as an expert witness in a court case or other legal proceeding on a matter related to the topic(s) of the guideline(s) that you will be involved in developing or overseeing? ___ Yes ___ No Do you expect that, over the next 12 months, you will serve as an expert witness in a legal proceeding? ___ Yes ___ No If ‘Yes’ to either question, please explain: [Insert material here]

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FINANCIAL AND PROFESSIONAL INTERESTS (The questions in this section concern both you and family members. For the purposes of this Declaration, a family member is a spouse, domestic partner, parent, child, or other relative with whom you have a comparably close tie.) 4. Payment for services or training Over the past 12 months, have you or a family member received payment for directly providing, or training other individuals to provide, health services related to the topic(s) of the guideline(s) that you will be involved in developing or overseeing? (Health services include professional, community-based, and peer support services.) ___ Yes ___ No Do you expect that, over the next 12 months, you or a family member will receive any payment for such activity? ___ Yes ___ No If ‘Yes’ to either question, please explain: [Insert material here] -------------------------------------- 5. Honoraria Over the past 12 months, have you or a family member received any honoraria for presentations or discussions of scientific or clinical issues related to the topic(s) of the guideline(s) that you will be involved in developing or overseeing? (Please include honoraria that were donated to charity.) ___ Yes ___ No Do you expect that, over the next 12 months, you or a family member will receive any such honoraria? ___ Yes ___ No If ‘Yes’ to either question, please explain: [Insert material here]

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-------------------------------------- 6. Royalties Over the past 12 months, have you or a family member received royalties or advance payments for books, films, or other materials that address scientific or clinical issues related to the topic(s) of the guideline(s) that you will be involved in developing or overseeing? (Please include royalties that were donated to charity.) ___ Yes ___ No Do you expect that, over the next 12 months, you or a family member will receive any such royalties or advance payments? ___ Yes ___ No If ‘Yes’ to either question, please explain: [Insert material here] -------------------------------------- 7. Endorsements Over the past 12 months, have you or a family member received monetary or other material compensation for endorsing a product or service related to the topic(s) of the guideline(s) that you will be involved in developing or overseeing? (Please include compensation that was donated to charity.) ___ Yes ___ No Do you expect that, over the next 12 months, you or a family member will receive such compensation for an endorsement? ___ Yes ___ No If ‘Yes’ to either question, please explain: [Insert material here]

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-------------------------------------- 8. Research funding Over the past 12 months, have you or a family member received funding, in the form of grants, fellowships, or contracts, for research or research training on scientific or clinical issues related to the topic(s) of the guideline(s) that you will be involved in developing or overseeing? ___ Yes ___ No Do you expect that, over the next 12 months, you or a family member will receive any such funding? ___ Yes ___ No If ‘Yes’ to either question, please explain: [Insert material here] -------------------------------------- 9. Employer Over the past 12 months, have you or a family member held a job with an employer that has economic, policy, or other interests in healthcare guidelines in general or in the particular topic(s) of the guideline(s) that you will be involved in developing or overseeing? (Please consider both full- and part-time positions and both permanent and temporary positions.) ___ Yes ___ No Do you expect that, over the next 12 months, you or a family member will hold a job with an employer that has such interests? ___ Yes ___ No If ‘Yes’ to either question, please explain: [Insert material here]

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-------------------------------------- 10. Roles in organizations Over the past 12 months, have you or a family member served in a governance, advisory, or other position in an organization (other than APA) that provides health services, promotes research related to health services, or develops or advocates for health service policies, related to the topic(s) of the guideline(s) that you will be involved in developing or overseeing? ___ Yes ___ No Do you expect that, over the next 12 months, you or a family member will serve in such a position? ___ Yes ___ No If ‘Yes’ to either question, please explain: [Insert material here] -------------------------------------- 11. Influence/ownership/stock in health-related firms Over the past 12 months, have you or a family member had a significant capacity to influence decisions of a firm or organization that conducts research or provides health services related to the topic(s) of the guideline(s) being developed? (Health services include professional, community-based, and peer support services.) ___ Yes ___ No Over the past 12 months, have you and/or any family member(s) held an ownership interest greater than 5% in such a firm? Have you and/or any family member(s) owned stock in such a firm that exceeded $10,000 in value at any time during the past 12 months? (Please consider the total amounts held by you and family members, e.g., whether the stock that your spouse and your parent own adds up to more than $10,000 in value.) ___ Yes ___ No Do you or any family member hold stock options of any value in such a firm? ___ Yes ___ No Do you expect that, over the next 12 months, you or a family member will have such capacity to influence a firm or have such ownership or stock interests? ___ Yes ___ No If ‘Yes’ to any of these questions, please explain:

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[Insert material here] INTERESTS RELATED TO APA (The questions in this section concern both you and family members. For the purposes of this Declaration, a family member is a spouse, domestic partner, parent, child, or other relative with whom you have a comparably close tie.) 12. APA roles

Over the past 12 months, have you or a family member been a member of any APA governance group, task force, or advisory body? (Please include roles in APA divisions.)

___ Yes ___ No Do you expect that, over the next 12 months, you or a family member will serve as a member of such an APA group?

___ Yes ___ No

If ‘Yes’ to either question, please explain:

[Insert material here] -------------------------------------- 13. Influence/ownership/stock in firms of interest to APA Over the past 12 months, have you or a family member had a significant capacity to influence decisions of a firm or organization that is an APA competitor, customer, or supplier? ___ Yes ___ No Over the past 12 months, have you and/or any family member(s) held an ownership interest greater than 5% in such a firm? Have you and/or any family member(s) owned stock in such a firm that exceeded $10,000 in value at any time during the past 12 months? (Please consider the total amounts held by you and family members, e.g., whether the stock that your spouse and your parent own adds up to more than $10,000 in value.) ___ Yes ___ No Do you or any family member hold stock options of any value in such a firm?

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___ Yes ___ No Do you expect that, over the next 12 months, you or a family member will have such capacity to influence a firm or have such ownership or stock interests? ___ Yes ___ No If ‘Yes’ to any of these questions, please explain: [Insert material here] --------------------------------------

14. Paid work with other firms that do business with APA

Over the past 12 months, have you or a family member been employed by or performed other work (including consulting) for a competitor, customer, or supplier of APA, regardless of the nature of that work? ___ Yes ___ No Do you expect that, over the next 12 months, you or a family member will be engaged in such employment or work? ___ Yes ___ No If ‘Yes’ to either question, please explain: [Insert material here] --------------------------------------

15. Business ties to APA

Over the past 12 months, have you or a family member conducted APA business of any kind, or arranged for such business, with a firm that is owned or controlled by you or a family member?

___ Yes ___ No

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Do you expect that, over the next 12 months, you or a family member will conduct or arrange for such business? ___ Yes ___ No If ‘Yes’ to either question, please explain: [Insert material here]

--------------------------------------

16. Ties to others seeking business with APA

Over the past 12 months, have you or a family member accepted any money, property, or anything of value from a person or firm doing or seeking to do business with APA?

___ Yes ___ No

Do you expect that, over the next 12 months, you or a family member will accept any money, property, or anything of value from a person or firm doing or seeking to do business with APA?

___ Yes ___ No If ‘Yes’ to either question, please explain: [Insert material here] --------------------------------------

17. Other economic benefits related to APA business

Over the past 12 months, have you or a family member received any direct or indirect economic benefit as a consequence of acquisition, lease, or sale by APA of any property, facilities, materials, or services?

___ Yes ___ No Over the past 12 months, have you or a family member received any other direct or indirect economic benefit related to APA business that are not covered in the previous questions?

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___ Yes ___ No Do you expect that, over the next 12 months, you or a family member will receive any such economic benefit?

___ Yes ___ No If ‘Yes’ to any of these questions, please explain: [Insert material here] OTHER RELEVANT INTERESTS (The questions in this section concern both you and family members. For the purposes of this Declaration, a family member is a spouse, domestic partner, parent, child, or other relative with whom you have a comparably close tie.) 18. Other professional activities Over the past 12 months, have you or a family member engaged in any other scientific, academic, clinical, business, or policy activities, either paid or unpaid, related to the topic(s) of the guideline(s) that you will be involved in developing or overseeing? (This question is asking about activities not already addressed in answers to the previous questions.) ___ Yes ___ No Do you expect that, over the next 12 months, you or a family member will engage in other such activities? ___ Yes ___ No If ‘Yes’ to either question, please explain: [Insert material here] --------------------------------------

19. Legal proceedings At any point over the last 12 months, have you or a family member been under prosecution for a crime? Have you or a family member been involved in any civil legal proceedings as either defendant or plaintiff? (Please include all such legal proceedings, including those not related to the topic(s) of the guideline(s) you will be involved in developing or overseeing.)

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___ Yes ___ No If ‘Yes’ to either question, please explain: [Insert material here] --------------------------------------

20. Misconduct At any point over the last 12 months, have you or a family member been formally charged with ethical, professional, or financial misconduct by any organization? (Please include all such charges, including those not related to the topic(s) of the guideline(s) you will be involved in developing or overseeing.) ___ Yes ___ No If ‘Yes,” please explain: [Insert material here]

--------------------------------------

21. Additional activities Is there any other information regarding your or family members’ activities, including interactions with organizations and individuals, that you believe is relevant to the guideline(s) that you will be involved in developing or overseeing or to your working with APA? Please focus on activities that may constitute actual, potential, or perceived conflicts of interest, and include activities that occurred more than 12 months ago or are expected to occur more than 12 months from now. ___ Yes ___ No If ‘Yes,” please explain: [Insert material here]

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--------------------------------------

22. Relationships Do you have any concerns that your work on guideline development or with APA could have a significant negative impact on any professional or personal relationships you have with mentors, students, trainees, colleagues, supervisors, funders, friends, or relatives? (For this question, please consider all relatives in addition to spouse, domestic partner, parents, and children.) ___ Yes ___ No If ‘Yes,’ please explain: [Insert material here] Finally, please read, complete, and sign the following statement:

I have read and I understand the requirements of APA's Conflict of Interest Policy above and I agree to abide by the Policy throughout the official term of my position in the APA clinical practice guideline initiative.

I have also fully and truthfully answered the questions in the Declaration of Interests above about all actual, potential, and perceived conflicts of interest.

If any new actual, potential, or perceived conflicts of interest arise, I agree to disclose them

immediately to APA staff and to the Chair or Vice Chair of any committee or Panel of which I am

a member.

________________________________ __________________ Signature (type name) Date Please email this document to Ms. Shannon Beattie at: sbeattie@apa.org REMINDER: Please attach a CV, résumé, or other materials if these are needed to provide complete answers.

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____________________________________________________________________________

**For APA Staff Use Only**

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Appendix C

Voting Procedures Established by Advisory Steering Committee (ASC)

1) What % should be considered a majority for winning a vote? The ASC agreed that at least 70% of the whole constituted panel would constitute a strong recommendation. For conditional recommendations, agreement among more than 50% with less than 20% of panel members preferring an alternative recommendation must be reached. The denominator for voting will be the number of the entire panel membership, except in special cases, to be determined by the ASC. Such cases could include the lack of participation by a particular member in the guideline development process. APA staff will consult with ASC liaisons to panels as needed regarding special cases. However, panel members who are normally participatory, but have missed crucial conversations and/or votes due to extenuating circumstances, will still be allowed to share their opinions.

2) Should dissenting opinions from members that disagree be added to recommendation statements?

The ASC agreed that there may be a section in final guideline documents for any dissenting opinions that panel members have. A footnote will disclose the number of dissenting panel members and possibly their names.

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Appendix D

Other Organizations’ Clinical Practice Guidelines on Overweight and Obesity in Children and Adolescents

AACE/ACE Obesity Task Force (1998). AACE/ACE Position statement on the prevention,

diagnosis, and treatment of obesity. Endocrine Practice, 4(5).

AHA/ACC/TOS (2013). 2013 AHA/ACC/TOS Guideline for the management of overweight and

obesity in adults: A report of the American College of Cardiology/American Heart

Association Task Force on Practice Guidelines and The Obesity Society. Circulation,

129(25). doi: 10.1161/01.cir.0000437739.71477.ee

American Academy of Family Physicians (2014). Summary of recommendations for clinical

preventive services. Leawood, KS: American Academy of Family Physicians; PMID

August, G. P., Caprio, S., Fennoy, I., Freemark, M., Kaufman, F. R., Lustig, R. H., . . . Montori,

V. M. (2008). Prevention and treatment of pediatric obesity: An Endocrine Society

Clinical Practice Guideline Based on Expert Opinion. The Journal of Clinical

Endocrinology & Metabolism, 93(12), 4576-4599. doi:10.1210/jc.2007-2458

Barlow, S. E. (2007). Expert committee recommendations regarding the prevention,

assessment, and treatment of child and adolescent overweight and obesity: Summary

report. Pediatrics, 120(4).

Barlow, S. E., & Dietz, W. H. (1998). Obesity evaluation and treatment: Expert committee

recommendations. Pediatrics, 102(3). doi:10.1542/peds.102.3.e29

Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children

and Adolescents: Summary Report. (2011). Pediatrics, 128(Supplement).

doi:10.1542/peds.2009-2107c

Guyatt, G., Oxman, A. D., Sultan, S., Brozek, J., Glasziou, P., Alonso-Coello, P., ...

Schünemann, H. J. (2013). GRADE guidelines: 11. Making an overall rating of

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confidence in effect estimates for a single outcome and for all outcomes. Journal of

Clinical Epidemiology, 66(2), 151-157. 10.1016/j.jclinepi.2012.01.006

Guyatt, G. H., Oxman, A. D., Vist, G., Kunz, R., Brozek, J., Alonso-Coello, P., . . . Schünemann,

H. J. (2011). GRADE guidelines: 4. Rating the quality of evidence--study limitations (risk

of bias). Journal of Clinical Epidemiology, 64(4), 407-415. doi:

10.1016/j.jclinepi.2010.07.017

National Health and Medical Research Council (2013) Clinical practice guidelines for the

management of overweight and obesity in adults, adolescents and children in Australia.

Melbourne: National Health and Medical Research Council.

National Institute for Health and Care Excellence (2013). Managing overweight and obesity

among children and young people: Lifestyle weight management services (NICE Public

Health Guidance 47). Retrieved from:

http://www.worldobesity.org/site_media/uploads/NICE-Child.pdf

Scottish Intercollegiate Guidelines Network (2010). Management of obesity: A national clinical

guideline (SIGN Public Health Guidance 115). Available from:

http://www.sign.ac.uk/pdf/sign115.pdf

Spear, B. A., Barlow, S. E., Ervin, C., Ludwig, D. S., Saelens, B. E., Schetzina, K. E., &

Taveras, E. M. (2007). Recommendations for treatment of child and adolescent

overweight and obesity. Pediatrics, 120(Supplement). doi:10.1542/peds.2007-2329f

Styne, D.M., Arslanian, S.A., Connor, E.L., Farooqi, I.S., Murad, M.H., Silverstein, J.H. &

Yanovski, J.A. (2017). Pediatric obesity- assessment, treatment, and prevention: An

Endocrine Society clinical practice guideline. The Journal of Clinical Endocrinology and

Metabolism, 102(3), 709-757. doi:10.1210/jc.2016-2573

US Preventive Services Task Force (2005). Screening and interventions for overweight children

and adolescents: Recommendation statement. Pediatrics, 116(1). doi:

10.1542/peds.2005-0302

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US Preventive Services Task Force (2010). Screening for obesity in children and adolescents:

US Preventive Services Task Force recommendation statement. Pediatrics, 125(2). doi:

10.1542/peds.2009-2037

US Preventive Services Task Force (June 2017). Final recommendation statement: Obesity in

children and adolescents: Screening.

https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationState

mentFinal/obesity-in-children-and-adolescents-screening1

Working Group of the Guideline for the Prevention and Treatment of Childhood and Juvenile

Obesity (2009). Clinical practice guideline for the prevention and treatment of childhood

and juvenile obesity. The Spanish National Healthcare System of the Spanish Ministry

for Health and Social Policy; Catalan Agency for Health Technology Assessment,

CAHTA no. 2007/25.

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Appendix E

Systematic Reviews on Medication and Surgery to Treat Overweight and Obesity in Children and Adolescents

Ells, L. J., Mead, E., Atkinson, G., Corpeleijn, E., Roberts, K., Viner, R., … Richter, B. (2015).

Surgery for the treatment of obesity in children and adolescents (review). Cochrane

Database of Systematic Reviews, 6(CD011740).

Herget, S., Rudolph, A., Hilbert, A., & Bluher, S. (2014). Psychosocial status and mental health

in adolescents before and after bariatric surgery: A systematic literature review. Obesity

Facts, 7, 233-245.

Mead, E., Brown, T., Rees, K., Azevedo, L. B., Whittaker, V., Jones, D., … Ells, L. J. (2017).

Diet, physical activity and behavioral interventions for the treatment of overweight or

obese children from the age of 6 to 11 years (Review). Cochrane Database of

Systematic Reviews, 6(CD012651).

O’Connor, E. A., Evans, C. V., Burda, B. U., Walsh, E. S., Eder, M., & Lozano, P. (2017).

Screening for obesity and intervention for weight management in children and

adolescents: Evidence report and systematic review for the US Preventive Services

Task Force. JAMA, 317(23).

Paulus, G. F., de Vaan, L. E. G., Verdam, F. J., Bouvy, N. D., Ambergen, T. A. W., & van Heurn,

L. W. E. (2015). Bariatric surgery in morbidly obese adolescents: A systematic review

and meta-analysis. Obesity Surgery, 25, 860-878.

Styne, D. M., Arslanian, S. A., Connor, E. L., Farooqi, I. S., Murad, M. H., Silverstein, J. H., …

Yanovski, J. A. (2017). Pediatric obesity – Assessment, treatment, and prevention: An

endocrine society clinical practice guideline. Journal of Clinical Endocrinology &

Metabolism, 102(3), 709-757.

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Willcox, K. & Brennan, L. (2014). Biopsychosocial outcomes of laparoscopic adjustable gastric

banding in adolescents: A systematic review of the literature. Obesity Surgery, 24, 1510-

1519.